Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With Colorectal Cancer (NCT NCT03828799)
NCT ID: NCT03828799
Last Updated: 2025-01-15
Results Overview
The physician determines pre-specified treatment-related toxicities and grades them by using the Common Terminology Criteria for Adverse Events (NCI-CTC Version 5). 1 - Mild: 2 - Moderate: 3 - Severe: 4 - Life-threatening: 5 - Death. Th evaluation is realized during the first three cycles.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
At the end of cycle 1 to 3 (each cycle is 14 days)
Results posted on
2025-01-15
Participant Flow
Recruitment period from 14/05/2019 to 15/10/2021.
Screening based on Uridine diphosphate-GlucuronosylTransferase (UGT1A1) status and DiHydroPyrimidine Dehydrogenase (DHPD) status with serum uracile \< 16 ng/ml.
Participant milestones
| Measure |
Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib 120 mg (PO)
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products is unchanged. Oxaliplatin, 5 FU Bolus and 5FU continuous are at 85 mg/m², 400 mg/m² and 2400 mg/m² respectively.
|
Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 120 mg (PO)
Cohort 2: Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib.
The dosage of the others products is unchanged. Oxaliplatin, 5FU Bolus and 5FU continuous are at 85 mg/m², 400 mg/m² and 2400 mg/m² respectively.
|
Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib 160 mg (PO)
Cohort 3: Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib.
The dosage of the others products is unchanged. Oxaliplatin, 5 FU Bolus and 5FU continuous are at 85 mg/m², 400 mg/m² and 2400 mg/m² respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
4
|
|
Overall Study
COMPLETED
|
3
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Experimental Irinotecan 150 mg/m² (IV) and Regorafenib 120 mg/m² (PO)
n=3 Participants
Cohort 1 : Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged i.e Oxaliplation at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental Irinotecan 180 mg/m² (IV) and Regorafenib 120 mg/m² (PO)
n=6 Participants
Cohort 2: Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged i.e Oxaliplation at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental Irinotecan 180 mg/m² (IV) and Regorafenib 160 mg/m² (PO)
n=4 Participants
Cohort 3: Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged i.e Oxaliplation at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
69 years
n=7 Participants
|
64.5 years
n=5 Participants
|
65 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Assessment of the patient's general condition using the ECOG scale
0
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Assessment of the patient's general condition using the ECOG scale
1
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Weight
|
71 Kilograms
n=5 Participants
|
69 Kilograms
n=7 Participants
|
78 Kilograms
n=5 Participants
|
69 Kilograms
n=4 Participants
|
|
Body Mass Index
|
22.9 kg/m²
n=5 Participants
|
27.2 kg/m²
n=7 Participants
|
24.3 kg/m²
n=5 Participants
|
27 kg/m²
n=4 Participants
|
|
Systolic blood pressure
|
130 mm/hg
n=5 Participants
|
127 mm/hg
n=7 Participants
|
140.5 mm/hg
n=5 Participants
|
130 mm/hg
n=4 Participants
|
|
Diastolic blood pressure
|
84 mm/hg
n=5 Participants
|
73 mm/hg
n=7 Participants
|
82 mm/hg
n=5 Participants
|
79 mm/hg
n=4 Participants
|
|
Tumor location
Right colon
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Tumor location
Left colon
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tumor location
Transverse colon
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tumor location
Recto-sigmoid junction
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Tumor location
Rectum
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Lymph node dissection
Lymph node dissection done
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Lymph node dissection
Lymph node dissection not done
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Adenocarcinoma type
well/moderately differentiated
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Adenocarcinoma type
Poorly differentiated/undifferentiated
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Adenocarcinoma type
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Depth of tumoral invasion in the wall of colon/rectum determined by pathologist
T3
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Depth of tumoral invasion in the wall of colon/rectum determined by pathologist
T4b
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Depth of tumoral invasion in the wall of colon/rectum determined by pathologist
TX (not operated)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Depth of tumoral invasion in the wall of colon/rectum determined by pathologist
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Comparison of number of patients with positive nodes versus negative nodes
N0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Comparison of number of patients with positive nodes versus negative nodes
N1
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Comparison of number of patients with positive nodes versus negative nodes
N2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Comparison of number of patients with positive nodes versus negative nodes
NX (not operated)
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Comparison of number of patients with positive nodes versus negative nodes
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Comparison of number of metastatic patients versus metastasis-free patients
M0
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Comparison of number of metastatic patients versus metastasis-free patients
M1
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Comparison of number of metastatic patients versus metastasis-free patients
M1a
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Metastatic location
Brain
|
0 metastatic sites
n=5 Participants
|
1 metastatic sites
n=7 Participants
|
0 metastatic sites
n=5 Participants
|
1 metastatic sites
n=4 Participants
|
|
Metastatic location
Liver
|
3 metastatic sites
n=5 Participants
|
5 metastatic sites
n=7 Participants
|
4 metastatic sites
n=5 Participants
|
12 metastatic sites
n=4 Participants
|
|
Metastatic location
Lymphatic nodes
|
0 metastatic sites
n=5 Participants
|
2 metastatic sites
n=7 Participants
|
1 metastatic sites
n=5 Participants
|
3 metastatic sites
n=4 Participants
|
|
Metastatic location
Bone
|
0 metastatic sites
n=5 Participants
|
0 metastatic sites
n=7 Participants
|
0 metastatic sites
n=5 Participants
|
0 metastatic sites
n=4 Participants
|
|
Metastatic location
Lung
|
1 metastatic sites
n=5 Participants
|
3 metastatic sites
n=7 Participants
|
1 metastatic sites
n=5 Participants
|
5 metastatic sites
n=4 Participants
|
|
Metastatic location
Peritoneum
|
1 metastatic sites
n=5 Participants
|
1 metastatic sites
n=7 Participants
|
0 metastatic sites
n=5 Participants
|
2 metastatic sites
n=4 Participants
|
PRIMARY outcome
Timeframe: At the end of cycle 1 to 3 (each cycle is 14 days)Population: Evaluable population for Dose-limiting toxicity (DLT). The list of DLTs is pre-specified in the protocol.
The physician determines pre-specified treatment-related toxicities and grades them by using the Common Terminology Criteria for Adverse Events (NCI-CTC Version 5). 1 - Mild: 2 - Moderate: 3 - Severe: 4 - Life-threatening: 5 - Death. Th evaluation is realized during the first three cycles.
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=3 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
n=6 Participants
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
n=4 Participants
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Number of Participants With Pre-specified Treatment-related Adverse Events
|
3 participants
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From baseline of patient until the first observed disease progressionPopulation: Intention to treat
Progression-free survival (PFS), defined as the time from date of inclusion to date of first observed disease progression (investigator's radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. . A central review of CT-scans is planned for patients found progression-free at 48 weeks. Patients without tumor progression or death at the time of analysis will be censored at their last date of tumor assessment.
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=3 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
n=6 Participants
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
n=4 Participants
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
12.5 Month
Interval 8.7 to 15.4
|
8.2 Month
Interval 3.1 to 9.1
|
5.1 Month
Interval 3.4 to 7.7
|
SECONDARY outcome
Timeframe: Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir).Population: Intention to treat
The disease control corresponds to stable, partial and complete responses determined by RECIST criteria. Criteria recist are based on lesions measurement determined by radiologist. Calculation : the values at the baseline minus the lowest values (nadir)
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=3 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
n=6 Participants
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
n=4 Participants
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Number of Patients With Disease Control
|
3 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir).Population: Intention to treat
The objective response corresponds to partial and complete responses determined by RECIST criteria. Criteria recist are based on lesions measurement determined by radiologist. Calculation : The values at the baseline minus the lowest values (nadir)
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=3 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
n=6 Participants
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
n=4 Participants
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Number of Participants With Objective Response
|
2 participants
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: From baseline to date of patient deathPopulation: Intention to treat
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=3 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
n=6 Participants
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
n=4 Participants
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Overall Survival (OS)
|
16.7 Month
Interval 15.6 to 18.0
|
13.3 Month
Interval 7.0 to 20.0
|
10.7 Month
Interval 7.2 to 15.0
|
SECONDARY outcome
Timeframe: Up to 6 months, from baseline of patient to the point where the values are the lowest (nadir).Population: Intention to treat
The percentage of regression of tumor size to its lowest value (nadir), compared with the pre-treatment tumor size (baseline), according to RECIST criteria (this is the reference method for evaluating cancer treatments based on the measurement of lesions by radiologist).
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=3 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
n=6 Participants
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
n=4 Participants
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
The Median of Regression of Tumor Size
|
55.3 Percentage
Interval 21.7 to 64.7
|
40.85 Percentage
Interval 1.1 to 61.7
|
60.75 Percentage
Interval 40.6 to 73.0
|
SECONDARY outcome
Timeframe: Up to 16 weeks (after 12 cycles of Folfirinox-R)Population: Population by step and evaluable for safety
Description by cycles of Regorafenib maintenance treatment after 12 cycles of Folfirinox-R
Outcome measures
| Measure |
Experimental: Irinotecan 150 mg/m² and Regorafenib 120 mg
n=13 Participants
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 120 mg
Cohort 2 : Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental : Irinotecan 180 mg/m² and Regorafenib 160 mg
Cohort 3 : Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatine at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Maintenance Treatment With Regorafenib Alone
All steps · No cycles received
|
8 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 1 : IRINOTECAN 150 / REGORAFENIB 120 · 2 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 1 : IRINOTECAN 150 / REGORAFENIB 120 · 3 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 1 : IRINOTECAN 150 / REGORAFENIB 120 · 4 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 1 : IRINOTECAN 150 / REGORAFENIB 120 · 6 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 1 : IRINOTECAN 150 / REGORAFENIB 120 · 8 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 1 : IRINOTECAN 150 / REGORAFENIB 120 · No cycles received
|
3 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 2 : IRINOTECAN 180 / REGORAFENIB 120 · 2 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 2 : IRINOTECAN 180 / REGORAFENIB 120 · 3 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 2 : IRINOTECAN 180 / REGORAFENIB 120 · 4 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 2 : IRINOTECAN 180 / REGORAFENIB 120 · 6 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 2 : IRINOTECAN 180 / REGORAFENIB 120 · 8 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 2 : IRINOTECAN 180 / REGORAFENIB 120 · No cycles received
|
3 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 3 : IRINOTECAN 180 / REGORAFENIB 160 · 2 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 3 : IRINOTECAN 180 / REGORAFENIB 160 · 3 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 3 : IRINOTECAN 180 / REGORAFENIB 160 · 4 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 3 : IRINOTECAN 180 / REGORAFENIB 160 · 6 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 3 : IRINOTECAN 180 / REGORAFENIB 160 · 8 cycles received
|
0 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
Step 3 : IRINOTECAN 180 / REGORAFENIB 160 · No cycles received
|
2 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
All steps · 2 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
All steps · 3 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
All steps · 4 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
All steps · 6 cycles received
|
1 Participants
|
—
|
—
|
|
Maintenance Treatment With Regorafenib Alone
All steps · 8 cycles received
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 16 weeks etc. through the end of treatmentPopulation: Blood samples were not analyzed because the number of patients per cohort was too low. Consequently, the data is not available and cannot be populated.
From baseline of first patient until the end of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately at 6 monthsPopulation: Blood samples were not analyzed because the number of patients per cohort was too low. Consequently, the data is not available and cannot be populated.
Through the treatment
Outcome measures
Outcome data not reported
Adverse Events
Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO)
n=3 participants at risk
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatin at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO)
n=6 participants at risk
Cohort 2: Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatin at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO)
n=4 participants at risk
Cohort 3: Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatin at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Intestinal subocclusive syndrom
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Pyelonephritis acute
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
Other adverse events
| Measure |
Experimental: Irinotecan 150 mg/m² (IV) and Regorafenib at 120 mg (PO)
n=3 participants at risk
Cohort 1: Participants were administered 150 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatin at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental: Irinotecan 180 mg/m² (IV) Cand Regorafenib at 120 mg (PO)
n=6 participants at risk
Cohort 2: Participants were administered 180 mg/m² of Irinotecan and 120 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatin at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
Experimental: Irinotecan 180 mg/m² (IV) and Regorafenib at 160 mg (PO)
n=4 participants at risk
Cohort 3: Participants were administered 180 mg/m² of Irinotecan and 160 mg of Regorafenib every 14 days.
The dosage of the others products are unchanged. Oxaliplatin at 85 mg/m², 5FU Bolus at 400 mg/m² and 5FU continuous at 2400 mg/m².
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
3/6 • Number of events 8 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
2/4 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Thrombopenia
|
33.3%
1/3 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
2/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Aphtous ulcer
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • Number of events 8 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
100.0%
6/6 • Number of events 25 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
100.0%
4/4 • Number of events 23 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Dysepsia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
83.3%
5/6 • Number of events 11 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
100.0%
4/4 • Number of events 7 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Rectal syndrome
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
2/4 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
2/4 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
General disorders
Asthenia
|
66.7%
2/3 • Number of events 9 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
100.0%
6/6 • Number of events 12 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
75.0%
3/4 • Number of events 10 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Immune system disorders
Drug hypersensitivy
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Infections and infestations
Erythema induratum
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Immune system disorders
Hepatitis E
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Immune system disorders
Oral candidiasis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Investigations
Blood alcaline phosphatase increased
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Investigations
Blood lactatce dehydrogenase increased
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Investigations
Gammaglutamyl transferase increased
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
2/4 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
3/6 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
75.0%
3/4 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
66.7%
4/6 • Number of events 13 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
75.0%
3/4 • Number of events 3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
3/6 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Distal wekness
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Dysgueusia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Dysphonia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Number of events 3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
66.7%
4/6 • Number of events 7 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
75.0%
3/4 • Number of events 9 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Nervous system disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Nocturia
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
50.0%
2/4 • Number of events 2 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 4 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
66.7%
4/6 • Number of events 6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
100.0%
4/4 • Number of events 24 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
0.00%
0/6 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
|
Investigations
Transaminase increased
|
0.00%
0/3 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
25.0%
1/4 • Number of events 1 • From the baseline up to one month after the last cycle of chemotherapy, up to 7 months (AE ans SAEs). From the baseline up to 20 months for all-cause mortality.
|
Additional Information
Representative of sponsor
Institut régional du Cancer de Montpellier
Phone: 467612446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place