Trial Outcomes & Findings for Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer (NCT NCT03785873)
NCT ID: NCT03785873
Last Updated: 2026-02-13
Results Overview
Based on Kaplan-Meier estimates.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 2 years after last dose of study treatment, average of 4 months
Results posted on
2026-02-13
Participant Flow
4 screen fails occured
4 patients enrolled but did not start study treatment. 3 due to declining health and 1 who selected alternative therapy. All patients enrolled experienced the same dosing.
Participant milestones
| Measure |
Phase 1b: Nal-Irinotecan and Nivolumab
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
Phase 2: Nal-Irinotecan and Nivolumab
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
20
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Phase 1b: Nal-Irinotecan and Nivolumab
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
Phase 2: Nal-Irinotecan and Nivolumab
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b: Nal-Irinotecan and Nivolumab
n=10 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
Phase 2: Nal-Irinotecan and Nivolumab
n=20 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
17 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
28 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=41 Participants
|
16 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=41 Participants
|
20 participants
n=1581 Participants
|
30 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: At 4 weeks after initiation of study treatmentPopulation: All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
Adverse events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.The patients accrued to the phase 2 portion of the trial were also observed for DLT during the first cycle of therapy given the same dose level was used.
Outcome measures
| Measure |
Nal-Irinotecan and Nivolumab
n=30 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|
|
Phase Ib: Incidence of Dose-limiting Toxicities (DLTs) of Drug Combination Nanoliposomal-Irinotecan, 5-fluorouracil, Leucovorin and Nivolumab
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years after last dose of study treatment, average of 4 monthsPopulation: All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
Based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Nal-Irinotecan and Nivolumab
n=30 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|
|
Median Progression-Free Survival (PFS)
|
4.1 months
Interval 1.9 to 9.9
|
SECONDARY outcome
Timeframe: Until discontinuation of study treatment, up to approximately 2 years after initiating study treatment or 3 years after first date of treatment initiation for those that remain on treatmentPopulation: All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
Reportable adverse events are defined by the study protocol and graded according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v5.0. The maximum grade per type, per patient is reported below.
Outcome measures
| Measure |
Nal-Irinotecan and Nivolumab
n=30 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|
|
Incidence of Treatment-related Adverse Events
Alanine aminotransferase increased- Grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Alkaline phosphatase increased- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Anemia- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Blood bilirubin increased- grade 3
|
2 Participants
|
|
Incidence of Treatment-related Adverse Events
Colitis- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Acute kidney injury- Grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Aspartate aminotransferase increased- grade 3
|
2 Participants
|
|
Incidence of Treatment-related Adverse Events
Biliary tract infection- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Diarrhea- grade 3
|
5 Participants
|
|
Incidence of Treatment-related Adverse Events
Enterocolitis- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
fatigue- grade 3
|
4 Participants
|
|
Incidence of Treatment-related Adverse Events
hyperglycemia- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
hyperglycemia- grade 4
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
hypokalemia- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
hypomagnesemia- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
mucositis oral- grade 3
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
myocarditis- grade 5
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Neutrophil count decreased- grade 3
|
2 Participants
|
|
Incidence of Treatment-related Adverse Events
Neutrophil count decreased- grade 4
|
1 Participants
|
|
Incidence of Treatment-related Adverse Events
Pneumonitis- grade 3
|
2 Participants
|
|
Incidence of Treatment-related Adverse Events
Sepsis- grade 5
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years after last dose of study treatment, average of 8.5 monthsPopulation: All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
Determined per the combined Response Evaluation Criteria in Solid Tumours (RECISTv1.1) and immune-related RECIST (irRECIST) criteria. Complete Response and Partial Response are included.
Outcome measures
| Measure |
Nal-Irinotecan and Nivolumab
n=30 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|
|
Overall Response Rate (ORR)
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
Outcome measures
| Measure |
Nal-Irinotecan and Nivolumab
n=30 Participants
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
|
|---|---|
|
Median Overall Survival (OS)
|
7.4 months
Interval 5.7 to 15.9
|
Adverse Events
Nal-Irinotecan and Nivolumab
Serious events: 22 serious events
Other events: 28 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Nal-Irinotecan and Nivolumab
n=30 participants at risk
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Biliary tract infection
|
10.0%
3/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Blood bilirubin increased
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Death NOS
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Nervous system disorders
Encephalopathy
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Enterocolitis
|
6.7%
2/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
clostridium difficile colitis
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
campylobacter colitis
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Cholangitis
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Biliary obstruction
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Metastatic intrahepatic cholangiocarcinoma
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Hyperglycemia
|
13.3%
4/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Hyponatremia
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Cardiac disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Lung infection
|
6.7%
2/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Nervous system disorders
Myasthenia gravis
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Cardiac disorders
Myocarditis
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
16.7%
5/30 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Pneumonitis
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.3%
1/30 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
Other adverse events
| Measure |
Nal-Irinotecan and Nivolumab
n=30 participants at risk
Nivolumab: Intravenous (IV) infusion 240 mg
Nanoliposomal-Irinotecan: Intravenous (IV) infusion 70 mg/m2
5-Fluorouracil: Intravenous (IV) infusion 2400 mg/m2
Leucovorin: Intravenous (IV) infusion 400 mg/m2
All study patients have been combined into one cohort as they all received the same treatment (Irinotecan 70 mg/m2, 5-Fluorouracil 2400 mg/m2, Leucovorin 400 mg/m2, Nivolumab 240 mg)
|
|---|---|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
2/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Sore throat
|
10.0%
3/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Thrush
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
5/30 • Number of events 16 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Back pain
|
13.3%
4/30 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
10/30 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Nervous system disorders
Arthralgia
|
13.3%
4/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Ascites
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Abdominal pain
|
36.7%
11/30 • Number of events 22 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Alkaline phosphatase increased
|
10.0%
3/30 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Anemia
|
26.7%
8/30 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Blood bilirubin increased
|
10.0%
3/30 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Chills
|
6.7%
2/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
8/30 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Diarrhea
|
76.7%
23/30 • Number of events 54 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Dizziness
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Eye disorders
Dry eye
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Dry mouth
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Dysgeusia
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Edema limbs
|
10.0%
3/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Fall
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Fatigue
|
60.0%
18/30 • Number of events 35 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Fever
|
10.0%
3/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Generalized edema
|
10.0%
3/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Generalized muscle weakness
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Headache
|
30.0%
9/30 • Number of events 12 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
3/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Hyperhidrosis
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Hyperthyroidism
|
10.0%
3/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
2/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
5/30 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Cardiac disorders
Hypotension
|
13.3%
4/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Insomnia
|
10.0%
3/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Mucositis oral
|
23.3%
7/30 • Number of events 18 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Muscle cramp
|
10.0%
3/30 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Nausea
|
63.3%
19/30 • Number of events 27 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Neutrophil count decreased
|
20.0%
6/30 • Number of events 11 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Pain
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Nervous system disorders
Paresthesia
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
Platelet count decreased
|
13.3%
4/30 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
5/30 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
3/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Renal and urinary disorders
Urinary incontinence
|
13.3%
4/30 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
15/30 • Number of events 22 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
General disorders
Watering eyes
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Weight loss
|
16.7%
5/30 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Investigations
White blood cell decreased
|
13.3%
4/30 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.7%
2/30 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of initial study treatment administration through 100 days after the last dose of study treatment, up to 2 years, and an average of 8.5 months per subject.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee IPD that underlie the results published in peer reviewed research articles, after deidentification. Investigators whose proposed use of the data is for meta-analysis, and has been approved by an independent review committee identified for this purpose. Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement.
- Publication restrictions are in place
Restriction type: OTHER