Trial Outcomes & Findings for Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines (NCT NCT04535401)
NCT ID: NCT04535401
Last Updated: 2026-08-21
Results Overview
A BOIN - Bayesian Optimal intervals trial design will be used to determine the MTD.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2026-08-21
Participant Flow
Participant milestones
| Measure |
Treatment (Elimusertib, FOLFIRI) - Dose Level -1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 10 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI) - Dose Level -1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI) - Dose Level 1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI) - Dose Level 1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines
Baseline characteristics by cohort
| Measure |
Treatment (Elimusertib, FOLFIRI) DL-1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 10 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI) DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI) DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI) DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.00 years
n=5 Participants
|
55.00 years
n=109 Participants
|
50.00 years
n=133 Participants
|
61.00 years
n=86 Participants
|
59.00 years
n=1912 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
3 Participants
n=1912 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
1 Participants
n=86 Participants
|
7 Participants
n=1912 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
1 Participants
n=86 Participants
|
10 Participants
n=1912 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
1 Participants
n=86 Participants
|
8 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
0 Participants
n=1912 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=1912 Participants
|
|
ECOG Performance Score
ECOG = 0
|
2 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
1 Participants
n=86 Participants
|
6 Participants
n=1912 Participants
|
|
Number of Lines of Prior Therapy
Four Prior lines of therapy
|
0 patients
n=5 Participants
|
2 patients
n=109 Participants
|
1 patients
n=133 Participants
|
0 patients
n=86 Participants
|
3 patients
n=1912 Participants
|
|
ECOG Performance Score
ECOG = 1
|
1 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
4 Participants
n=1912 Participants
|
|
Tumor type
Colorectal cancer
|
2 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
1 Participants
n=86 Participants
|
6 Participants
n=1912 Participants
|
|
Tumor type
Pancreatic cancer
|
1 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
3 Participants
n=1912 Participants
|
|
Tumor type
Small Intestinal cancer
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=86 Participants
|
1 Participants
n=1912 Participants
|
|
Number of Lines of Prior Therapy
Two Prior lines of therapy
|
2 patients
n=5 Participants
|
1 patients
n=109 Participants
|
0 patients
n=133 Participants
|
0 patients
n=86 Participants
|
3 patients
n=1912 Participants
|
|
Number of Lines of Prior Therapy
Three Prior lines of therapy
|
1 patients
n=5 Participants
|
0 patients
n=109 Participants
|
1 patients
n=133 Participants
|
1 patients
n=86 Participants
|
3 patients
n=1912 Participants
|
|
Number of Lines of Prior Therapy
Five Prior lines of therapy
|
0 patients
n=5 Participants
|
0 patients
n=109 Participants
|
1 patients
n=133 Participants
|
0 patients
n=86 Participants
|
1 patients
n=1912 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Unable to define the MTD as the combination was associated with clinically significant and prohibitive toxicity.
A BOIN - Bayesian Optimal intervals trial design will be used to determine the MTD.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Elimusertib (BAY 1895344) in Combination With Irinotecan, Fluorouracil, and Leucovorin (FOLFIRI)
|
NA mg/m2
MTD not determined
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Treated patients who were evaluated for DLTs.
Percentage of Patients Who Experienced Dose Limiting Toxicities (DLTs) , per CTCAE v5.0
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Patients Who Experienced DLTs
|
33.3 percentage of patients
Interval 0.8 to 90.6
|
66.7 percentage of patients
Interval 9.4 to 99.2
|
33.3 percentage of patients
Interval 0.8 to 90.6
|
100 percentage of patients
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI): DL-1B and Treatment (Elimusertib, FOLFIRI) DL1B arms were not included as the treatment schedule was changed and no Lead in occurred.
Concentration Maximum (Cmax) of irinotecan and 5FU in Lead-in phase.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Cmax of Irinotecan (Lead in)
|
1299 µg/L
Standard Deviation 1.14
|
1732 µg/L
Standard Deviation 1.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI): DL-1B and Treatment (Elimusertib, FOLFIRI) DL1B arms were not included as the treatment schedule was changed and no Lead in occurred.
Area Under the Curve (AUC) of irinotecan and 5FU in Lead-in phase.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
AUC of Irinotecan (Lead in)
|
8.79 mg/L•h
Standard Deviation 1.11
|
11.2 mg/L•h
Standard Deviation 1.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI): DL-1B and Treatment (Elimusertib, FOLFIRI) DL1B arms were not included as the treatment schedule was changed and no Lead in occurred.
Area Under the Curve (AUC) of irinotecan and 5FU in Lead-in phase.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
AUC of 5FU (Lead-in)
|
16.0 mg/L•h
Standard Deviation 1.71
|
13.4 mg/L•h
Standard Deviation 1.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI) DL1B arm is not included as no PK samples were obtained.
Concentration Maximum (Cmax) of irinotecan in Combination (BAY + 5FU and Irinotecan) phase.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Cmax of Irinotecan (Combination)
|
1493 µg/L
Standard Deviation 1.31
|
1019 µg/L
Standard Deviation 1.73
|
1474 µg/L
Standard Deviation 1.05
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI) DL1B arm is not included as no PK samples were obtained.
Area Under the Curve (AUC) of irinotecan in Combination (BAY + 5FU and Irinotecan) phase.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
AUC of Irinotecan (Combination)
|
10.6 mg/L•h
Standard Deviation 1.37
|
7.80 mg/L•h
Standard Deviation 1.62
|
10.3 mg/L•h
Standard Deviation 1.43
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI) DL1B arm is not included as no PK samples were obtained.
Area Under the Curve (AUC) of 5FU in Combination (BAY + 5FU and Irinotecan) phase
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
AUC of 5FU (Combination)
|
17.5 mg/L•h
Standard Deviation 1.47
|
19.7 mg/L•h
Standard Deviation NA
One patient, thus SD not applicable
|
14.8 mg/L•h
Standard Deviation 1.48
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI) DL1B arm is not included because patients from that arm did not contribute data to this outcome measure analysis.
Concentration maximum (Cmax) of BAY 1895344.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Cmax of BAY 1895344
|
251 µg/L
Standard Deviation 1.17
|
531 µg/L
Standard Deviation 1.43
|
496 µg/L
Standard Deviation 1.59
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who provided PK samples. Treatment (Elimusertib, FOLFIRI) DL1B arm is not included because patients from that arm did not contribute data to this outcome measure analysis.
Area Under the Curve of BAY 1895344.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
AUC-6 of BAY 1895344
|
0.96 mg/L•h
Standard Deviation 1.26
|
1.65 mg/L•h
Standard Deviation 1.40
|
1.77 mg/L•h
Standard Deviation 1.43
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Patients treated with BAY1895344 who provide PK samples. Treatment (Elimusertib, FOLFIRI) DL1B arm is not included because patients from that arm did not contribute data to this outcome measure analysis.
AUC of BAY 1895344
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
AUC of BAY 1895344
|
0.96 mg/L•h
Standard Deviation 1.26
|
1.65 mg/L•h
Standard Deviation 1.40
|
1.77 mg/L•h
Standard Deviation 1.43
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who were radiologically evaluable.
Percent probability of Complete Response (CR) or Partial Response (PR) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of patients
Interval 0.0 to 84.2
|
0 percentage of patients
Interval 0.0 to 84.2
|
0 percentage of patients
Interval 0.0 to 84.2
|
NA percentage of patients
no patients had response evaluation
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who were radiologically evaluable.
Percent probability of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
50 percentage of patients
Interval 1.3 to 98.7
|
50 percentage of patients
Interval 1.3 to 98.7
|
100 percentage of patients
Interval 15.8 to 100.0
|
NA percentage of patients
no patients had response evaluation
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Treated patients who were radiologically evaluable.
Number of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Best Response
Stable Disease (SD)
|
1 percentage of patients
|
1 percentage of patients
|
2 percentage of patients
|
NA percentage of patients
no patients had response evaluation
|
|
Best Response
Progressive Disease (PD)
|
1 percentage of patients
|
1 percentage of patients
|
0 percentage of patients
|
NA percentage of patients
no patients had response evaluation
|
SECONDARY outcome
Timeframe: Up to 24 months post treatmentPopulation: Treated patients who were radiologically evaluable. Dose Level 1B is not included because there were no evaluable patients.
Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) - by Dose Level
|
3.00 months
Interval 2.0 to
Too few participants (n=3) and all patients either died or censored early
|
2.0 months
Interval 2.0 to
Too few participants (n=2) and the final participant was censored at 9 months
|
7.00 months
Too few participants (n=2) and all patients either died or censored early
|
—
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Treated patients who were radiologically evaluable. For -1B Dose level there are two patients, where one patient had progression at 2 months, another patient was censored at 9 months.
Proportion of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
12-month Progression-free Survival (PFS) - by Dose Level
|
0 proportion of patients
There were no patients who are under survival follow up after 1 year. Some patients were censored before 1 year
|
0.5 proportion of patients
Interval 0.01 to 0.91
|
0 proportion of patients
There were no patients who are under survival follow up after 1 years. Some patients were censored before 1 year
|
—
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: Treated patients who were radiologically evaluable.
Proportion of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=2 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
24-month Progression-free Survival (PFS) - by Dose Level
|
0 proportion of patients
There were no patients who are under survival follow up after 2 years. Some patients were censored before 2 years
|
0.5 proportion of patients
Interval 0.01 to 0.91
|
0 proportion of patients
There were no patients who are under survival follow up after 2 years. Some patients were censored before 2 years
|
—
|
SECONDARY outcome
Timeframe: Up to 24 months post treatmentPopulation: Treated patients who were radiologically evaluable.
Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) - Total Population
|
7.00 months
Interval 2.0 to
Upper bound of 95% CI not reached due to insufficient number of participants with events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Patients at Dose Levels (elimusertib, FOLFIRI) DL-1 + DL-1B + DL1 + DL1B who were radiologically evaluable.
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
12-month Progression-free Survival (PFS) - Total Population
|
0 percentage of patients
Interval 0.0 to 60.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: Patients at Dose Levels (elimusertib, FOLFIRI) DL-1 + DL-1B + DL1 + DL1B who were radiologically evaluable.
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
24-month Progression-free Survival (PFS) - Total Population
|
0 percentage of patients
Interval 0.0 to 60.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 months post treatmentPopulation: All trial participants
Median number of months patients are alive from start of treatment until death while on study will be estimated within disease cohorts (KM estimator), with 95% CI.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Overall Survival (OS) - by Dose Level
|
NA months
Interval 2.0 to
Too few participants and the final participant was censored at 4 months
|
3.00 months
Interval 3.0 to
Too few participants and the final participant was censored at 9 months
|
NA months
Median is NA because all three patients were censored, so the OS did not reach 0.5. The 95% CI is NA due to too few participants and all were censored.
|
NA months
Median is NA because all three patients were censored, so the OS did not reach 0.5. The 95% CI is NA due to too few participants and all were censored.
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: All trial participants
Proportion of patients alive estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of death.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
12- Month Overall Survival (OS) - By Dose Level
|
0.67 proportion of patients
Interval 0.05 to 0.95
|
0.5 proportion of patients
Interval 0.01 to 0.91
|
1.00 proportion of patients
There were no patients who are under survival follow up after 1 year. All patients were censored before 1 year
|
1.00 proportion of patients
There were no patients who are under survival follow up after 1 year. All patients were censored before 1 year
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: All trial participants
Proportion of patients alive estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of death while on study.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=3 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=3 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=1 Participants
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
24-month Overall Survival (OS)
|
0.67 proportion of patients
Interval 0.05 to 0.95
|
0.5 proportion of patients
Interval 0.01 to 0.91
|
1.00 proportion of patients
There were no patients who are under survival follow up after 2 years. All patients were censored before 2 years
|
1.0 proportion of patients
There were no patients who are under survival follow up after 2 years. All patients were censored before 2 years
|
SECONDARY outcome
Timeframe: Up to 2 years post treatmentPopulation: All trial participants
Median number of months patients alive from start of treatment until death while on study will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Overall Survival (OS) - Total Population
|
NA months
Interval 2.0 to
Median is NA because only 2 of the total 10 patients died, so the OS at the end of study was 2/10=0.2, never reached 0.5. Upper bound of 95% CI is NA because there were too few events (event number =2), and the last several participants were censored.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: All trial participants
Proportion of patients alive estimated by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
12-month Overall Survival (OS) - Total Population
|
0 Proportion of patients
Interval 0.0 to 84.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 24 monthsPopulation: All trial participants
Proportion of patients alive estimated by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment.
Outcome measures
| Measure |
Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI)
n=10 Participants
Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
|
Treatment (Elimusertib, FOLFIRI): DL-1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
24-month Overall Survival (OS) - Total Population
|
0 proportion of patients
Interval 0.0 to 84.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Samples not taken as dose expansion cohort not conducted. This was only to be conducted in the Dose Expansion period.
Will be assessed by immunohistochemistry (IHC) and PFS. The association between ATM and responses will be described, with a table outlining patients who achieved progressive disease, stable disease, partial or complete responses and whether they exhibited ATM expression by IHC or not.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Blood samples not taken as dose expansion cohort not conducted.
Signaling during the pharmacokinetics (PK) lead-in and in combination with BAY 1895344 will be compared with a non-parametric paired test (e.g. Wilcoxon rank test), at a significance level at p \< 0.05. For tumors, this will be performed only for patients in the dose expansion cohorts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year post treatmentPopulation: Samples not taken as dose expansion cohort not conducted.
Signaling during the PK lead-in and in combination with BAY 1895344 will be compared with a non-parametric paired test (e.g. Wilcoxon rank test), at a significance level at p \< 0.05. For tumors, this will be performed only for patients in the dose expansion cohorts.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year post treatmentLogistic regression and proportional hazards (Cox) regression will be used to assess the relationships between exposure and response and toxicity; exposure-response will be assessed within disease cohorts of sufficient size, while exposure-toxicity will pool all patients. All patients will be used for the E-R analyses. Advanced population PK methods may be employed at a later stage to assess the link between drug exposure and biological effects and efficacy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year post treatmentAssessed by whole exome sequencing and ribonucleic acid sequencing. The efficacy analyses will be repeated by DDR tumor mutation status, but these analyses will have limited sample sizes and will not be adequately powered for statistical comparisons.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Elimusertib, FOLFIRI): DL-1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment (Elimusertib, FOLFIRI): DL-1B
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment (Elimusertib, FOLFIRI): DL1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment (Elimusertib, FOLFIRI): DL1B
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Elimusertib, FOLFIRI): DL-1
n=10 participants at risk；n=3 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 10 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=10 participants at risk；n=3 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=10 participants at risk；n=3 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=10 participants at risk；n=1 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Esophagitis
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
Other adverse events
| Measure |
Treatment (Elimusertib, FOLFIRI): DL-1
n=10 participants at risk；n=3 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 10 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL-1B
n=10 participants at risk；n=3 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1
n=10 participants at risk；n=3 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given BID D1,2,15,16 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
Treatment (Elimusertib, FOLFIRI): DL1B
n=10 participants at risk；n=1 participants at risk
Patients receive elimusertib PO and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Diagnostic Imaging: Undergo imaging
Elimusertib: Given QD D2,3,16,17 - 20 mg
Fluorouracil: Given IV - Day 1 and 15 \[Q2W\]) - 2000 mg/m2
Irinotecan Hydrochloride: Given IV - Day 1 and 15 \[Q2W\]) - 150 mg/m2
Leucovorin Calcium: Given IV - Day 1 and 15 \[Q2W\]) - 20 mg/m2
|
|---|---|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Endocrine disorders
Diabetes mellitus
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Eye disorders
Eye twitching
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Bloody stools
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
INR increased
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
LDH increased
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
PTT increase
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
Weight loss
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
3/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Right Groin pain
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
100.0%
1/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
66.7%
2/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/3 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
0.00%
0/1 • Adverse Events data were collected for 2 years, 7 months. All-Cause Mortality data were collected for 2 years, 8 months.
|
Additional Information
Barbara Stadterman, MPH, MSCCR, CCRP
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60