Trial Outcomes & Findings for Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer (NCT NCT02393755)
NCT ID: NCT02393755
Last Updated: 2021-07-08
Results Overview
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions. Will be summarized using standard Kaplan-Meier methods.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
At 18 weeks
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
Dose Level 1: Capecitabine at 2000 mg/2, Nintedanib at 150 mg
Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
Dose Level 2: Capecitabine at 2000 mg/m2, Nintedanib at 200 mg
Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
39
|
|
Overall Study
COMPLETED
|
3
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
Dose Level 1: Capecitabine at 2000 mg/2, Nintedanib at 150 mg
Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
Dose Level 2: Capecitabine at 2000 mg/m2, Nintedanib at 200 mg
Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg
n=3 Participants
Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
n=39 Participants
Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=99 Participants
|
57.3 years
n=107 Participants
|
57.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
ECOG Status at Baseline
Grade 0
|
2 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
ECOG Status at Baseline
Grade 1
|
1 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Body Weight
|
69.2 Kilograms (kg)
n=99 Participants
|
77.8 Kilograms (kg)
n=107 Participants
|
77.2 Kilograms (kg)
n=206 Participants
|
|
Presence of liver metastasis
|
3 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At least 21 days.Population: Patients who were evaluable for DLTs
The recommended Phase II dose is of the Nintedanib and Capecitabine combination is defined as the dose level that causes dose limiting toxicities (DLTs) in ≤ 1 out of 6 patients at highest dose level below the maximally administered dose. Capecitabine is fixed dose at 2000 mg/m2; while Nintedanib is evaluated at 150mg (dose level 1) and 200 mg (dose level 2).
Outcome measures
| Measure |
Treatment (Capecitabine, Nintedanib)
n=9 Participants
Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
To Examine the DLT
|
200 mg
|
PRIMARY outcome
Timeframe: At 18 weeksPopulation: All treated and eligible patients at dose level 2
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions. Will be summarized using standard Kaplan-Meier methods.
Outcome measures
| Measure |
Treatment (Capecitabine, Nintedanib)
n=36 Participants
Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II)
|
41.7 percentage of participants
Interval 29.2 to 55.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All treated and eligible patients at dose level 2
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions. Estimates of median PFS will be obtained with corresponding 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Capecitabine, Nintedanib)
n=36 Participants
Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Median PFS (Phase II)
|
3.4 months
Interval 2.1 to 4.2
|
SECONDARY outcome
Timeframe: From the date of enrollment to the time of death, assessed up to 2 yearsPopulation: All treated and eligible patients at dose level 2
Overall survival is defined as time from date of subject enrollment to the date of death due to any cause. Estimates of median OS will be obtained with corresponding 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Capecitabine, Nintedanib)
n=36 Participants
Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Median OS (Phase II)
|
8.9 months
Interval 5.9 to 13.8
|
SECONDARY outcome
Timeframe: After every 3 cycles (9 weeks) of therapy.Population: All treated and eligible patients at dose level 2
Overall Response is defined as Complete Response: Disappearance of all target lesions and any lymph nodes must have a reduction in short axis to \< 10 mm; or Partial Response: At least a 30% decrease in the sum of diameters of target lesions; or Stable Disease: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Treatment (Capecitabine, Nintedanib)
n=36 Participants
Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Objective Response Rate
|
58.3 percentage of participants
Interval 44.7 to 70.8
|
SECONDARY outcome
Timeframe: Up to 30 days after the last dose of study drugPopulation: All treated and eligible patients at dose level 2
Number of Participants with Adverse Events, Graded According to the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).
Outcome measures
| Measure |
Treatment (Capecitabine, Nintedanib)
n=36 Participants
Patients receive capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Grade 4
|
1 Participants
|
|
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Grade 5
|
3 Participants
|
|
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Grade 1
|
3 Participants
|
|
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Grade 2
|
13 Participants
|
|
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Grade 3
|
16 Participants
|
Adverse Events
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
Serious events: 10 serious events
Other events: 39 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg
n=3 participants at risk
Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
n=39 participants at risk
Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
Other adverse events
| Measure |
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg
n=3 participants at risk
Dose Level (Arm) 1: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 150 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 150 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
n=39 participants at risk
Dose Level (Arm) 2: Capecitabine at 2000 mg/m2 PO daily and Nintedanib at 200 mg PO bid
Capecitabine at 2000 mg/m2 will be administration will be twice daily for two weeks (the first 2 weeks of each 21 day cycle), followed by a 1 week rest. Nintedanib 2000 mg will be administered twice daily for 21 days (i.e., 1 complete 3-week cycle). Both capecitabine and nintedanib may be taken together, with water, within 30 minutes following a meal. Doses should be separated by approximately 12 hours, with the PM dose being 12 hours (+/- 2 hours) after the AM dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
35.9%
14/39 • Number of events 25 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
12.8%
5/39 • Number of events 8 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
12.8%
5/39 • Number of events 6 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
25.6%
10/39 • Number of events 10 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
28.2%
11/39 • Number of events 14 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
56.4%
22/39 • Number of events 49 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 6 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
69.2%
27/39 • Number of events 45 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • Number of events 7 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
12.8%
5/39 • Number of events 5 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
66.7%
26/39 • Number of events 45 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Asthenia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Chills
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
59.0%
23/39 • Number of events 48 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Medical device pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Oedema
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
15.4%
6/39 • Number of events 6 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
General disorders
Swelling
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 6 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Legionella infection
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
0.00%
0/39 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
41.0%
16/39 • Number of events 23 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
48.7%
19/39 • Number of events 31 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
41.0%
16/39 • Number of events 25 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
25.6%
10/39 • Number of events 16 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 5 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Platelet count
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Transferrin saturation decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Urine protein, quantitative
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
17.9%
7/39 • Number of events 10 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
12.8%
5/39 • Number of events 7 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
41.0%
16/39 • Number of events 27 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
10.3%
4/39 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
28.2%
11/39 • Number of events 25 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
12.8%
5/39 • Number of events 9 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
25.6%
10/39 • Number of events 13 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
10.3%
4/39 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
12.8%
5/39 • Number of events 7 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone marrow leukaemic cell infiltration
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
20.5%
8/39 • Number of events 8 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Dysarthria
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
0.00%
0/39 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
20.5%
8/39 • Number of events 9 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
23.1%
9/39 • Number of events 10 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
10.3%
4/39 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 7 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
20.5%
8/39 • Number of events 12 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
20.5%
8/39 • Number of events 11 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
10.3%
4/39 • Number of events 4 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
20.5%
8/39 • Number of events 9 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
2/3 • Number of events 11 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
38.5%
15/39 • Number of events 36 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
2.6%
1/39 • Number of events 1 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
7.7%
3/39 • Number of events 3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
5.1%
2/39 • Number of events 2 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 7 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
23.1%
9/39 • Number of events 32 • Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days
All treated and eligible patients
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place