Trial Outcomes & Findings for Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer (NCT NCT00433550)
NCT ID: NCT00433550
Last Updated: 2017-08-24
Results Overview
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
36 weeks
Results posted on
2017-08-24
Participant Flow
Prior to registration, patients were tested for UGT1A1 TA indel genotype of 6/6, 6/7, or 7/7. Patients were grouped into one of three treatment groups depending on UGT1A1 genotype. All other genotypes were ineligible. The endpoints of this study are not to compare results between the UGT1A1 types, but to analyze as one combined cohort.
Participant milestones
| Measure |
Group 1 (6/6 UGT1A1 Genotype)
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 2 (6/7 UGT1A1 Genotype)
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 3 (7/7 UGT1A1 Genotype)
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
10
|
6
|
|
Overall Study
COMPLETED
|
17
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Baseline characteristics by cohort
| Measure |
Group 1 (6/6 UGT1A1 Genotype)
n=17 Participants
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 2 (6/7 UGT1A1 Genotype)
n=10 Participants
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 3 (7/7 UGT1A1 Genotype)
n=6 Participants
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
66.5 years
n=7 Participants
|
62.5 years
n=5 Participants
|
64 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
Outcome measures
| Measure |
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
n=32 Participants
Group 1 (6/6 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.
Group 3 (7/7 UGT1A1 genotype):
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|
|
Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
|
.38 proportion of patients
Interval 0.21 to 0.56
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
n=32 Participants
Group 1 (6/6 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.
Group 3 (7/7 UGT1A1 genotype):
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|
|
Overall Survival
|
13.4 months
Interval 10.5 to 18.1
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
n=32 Participants
Group 1 (6/6 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.
Group 3 (7/7 UGT1A1 genotype):
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|
|
Progression Free Survival
|
8.9 months
Interval 4.7 to 10.8
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients who achieved a CR or PR are included in this analysis.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
n=12 Participants
Group 1 (6/6 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.
Group 3 (7/7 UGT1A1 genotype):
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|
|
Duration of Response
|
9.0 months
Interval 7.8 to
Too few events have occurred to estimate the upper 95% Confidence Interval.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
n=32 Participants
Group 1 (6/6 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype):
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.
Group 3 (7/7 UGT1A1 genotype):
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|
|
Time to Treatment Failure
|
6.7 months
Interval 4.3 to 10.6
|
Adverse Events
Group 1 (6/6 UGT1A1 Genotype)
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 2 (6/7 UGT1A1 Genotype)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3 (7/7 UGT1A1 Genotype)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (6/6 UGT1A1 Genotype)
n=17 participants at risk
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 2 (6/7 UGT1A1 Genotype)
n=10 participants at risk
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 3 (7/7 UGT1A1 Genotype)
n=6 participants at risk
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
1/17 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
17.6%
3/17 • Number of events 6
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
23.5%
4/17 • Number of events 5
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.8%
2/17 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
3/17 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Death
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Catheter related infection
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Bilirubin increased
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Leukocyte count decreased
|
17.6%
3/17 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Neutrophil count decreased
|
23.5%
4/17 • Number of events 6
|
30.0%
3/10 • Number of events 3
|
0.00%
0/6
|
|
Investigations
Platelet count decreased
|
11.8%
2/17 • Number of events 4
|
0.00%
0/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
17.6%
3/17 • Number of events 5
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Thrombosis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
Other adverse events
| Measure |
Group 1 (6/6 UGT1A1 Genotype)
n=17 participants at risk
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 2 (6/7 UGT1A1 Genotype)
n=10 participants at risk
Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
Group 3 (7/7 UGT1A1 Genotype)
n=6 participants at risk
Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
76.5%
13/17 • Number of events 120
|
100.0%
10/10 • Number of events 58
|
100.0%
6/6 • Number of events 57
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
|
Eye disorders
Eye disorder
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Number of events 4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
94.1%
16/17 • Number of events 66
|
70.0%
7/10 • Number of events 25
|
66.7%
4/6 • Number of events 19
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/17
|
30.0%
3/10 • Number of events 3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Mucositis oral
|
17.6%
3/17 • Number of events 4
|
40.0%
4/10 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
88.2%
15/17 • Number of events 71
|
70.0%
7/10 • Number of events 31
|
100.0%
6/6 • Number of events 20
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.9%
1/17 • Number of events 2
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
58.8%
10/17 • Number of events 39
|
40.0%
4/10 • Number of events 13
|
100.0%
6/6 • Number of events 16
|
|
General disorders
Fatigue
|
29.4%
5/17 • Number of events 10
|
60.0%
6/10 • Number of events 16
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Immune system disorders
Hypersensitivity
|
5.9%
1/17 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
|
Immune system disorders
Immune system disorder
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Gastric infection
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Gingival infection
|
5.9%
1/17 • Number of events 2
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Bilirubin increased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Leukocyte count decreased
|
64.7%
11/17 • Number of events 45
|
70.0%
7/10 • Number of events 26
|
50.0%
3/6 • Number of events 16
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
58.8%
10/17 • Number of events 39
|
70.0%
7/10 • Number of events 26
|
50.0%
3/6 • Number of events 13
|
|
Investigations
Platelet count decreased
|
64.7%
11/17 • Number of events 48
|
50.0%
5/10 • Number of events 9
|
16.7%
1/6 • Number of events 17
|
|
Investigations
Weight loss
|
11.8%
2/17 • Number of events 2
|
10.0%
1/10 • Number of events 3
|
33.3%
2/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/17
|
20.0%
2/10 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
17.6%
3/17 • Number of events 6
|
0.00%
0/10
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
33.3%
2/6 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • Number of events 2
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Laryngeal
|
17.6%
3/17 • Number of events 9
|
20.0%
2/10 • Number of events 9
|
16.7%
1/6 • Number of events 5
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Number of events 3
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
88.2%
15/17 • Number of events 98
|
70.0%
7/10 • Number of events 41
|
83.3%
5/6 • Number of events 33
|
|
Nervous system disorders
Taste alteration
|
5.9%
1/17 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/17
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.3%
6/17 • Number of events 13
|
50.0%
5/10 • Number of events 13
|
16.7%
1/6 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
47.1%
8/17 • Number of events 13
|
20.0%
2/10 • Number of events 6
|
16.7%
1/6 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
82.4%
14/17 • Number of events 81
|
90.0%
9/10 • Number of events 53
|
83.3%
5/6 • Number of events 51
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
41.2%
7/17 • Number of events 11
|
20.0%
2/10 • Number of events 4
|
0.00%
0/6
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/17
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60