Trial Outcomes & Findings for Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (NCT NCT04329949)
NCT ID: NCT04329949
Last Updated: 2023-11-18
Results Overview
Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by Blinded Independent Central Review (BICR). Tumor assessment consisted of computerized tomography (CT) scan or, with Sponsor approval, magnetic resonance imaging (MRI). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters (SOD) of target lesions.
TERMINATED
PHASE3
43 participants
Baseline and up to 32 weeks
2023-11-18
Participant Flow
Patients were recruited at 18 study sites in the United States.
Participant milestones
| Measure |
Relacorilant With Nab-paclitaxel
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Relacorilant With Nab-paclitaxel
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Overall Study
Death
|
36
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Termination of study by sponsor
|
3
|
Baseline Characteristics
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Age, Continuous
|
65.2 Years
STANDARD_DEVIATION 8.14 • n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 32 weeksPopulation: Intent-to-Treat (ITT) Population: Patients enrolled and treated with at least 1 dose of study treatment
Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by Blinded Independent Central Review (BICR). Tumor assessment consisted of computerized tomography (CT) scan or, with Sponsor approval, magnetic resonance imaging (MRI). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters (SOD) of target lesions.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
No response
|
43 Participants
|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Complete response
|
0 Participants
|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Partial response
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 48 weeksPopulation: ITT Population
Percentage of patients with measurable disease at baseline who achieved confirmed CR or PR per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Objective Response Rate (ORR) Per Investigator Assessment
Complete response
|
0 Participants
|
|
Objective Response Rate (ORR) Per Investigator Assessment
Partial response
|
0 Participants
|
|
Objective Response Rate (ORR) Per Investigator Assessment
No response
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 32 weeksPopulation: Evaluable Population: Patients in the ITT population who had at least 1 post-baseline radiographic tumor assessment
To evaluate the best overall response of CR, PR, stable disease (SD), or PD per RECIST v1.1. as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=31 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Best Overall Response (BOR)
Complete response
|
0 Participants
|
|
Best Overall Response (BOR)
Partial response
|
0 Participants
|
|
Best Overall Response (BOR)
Stable disease
|
20 Participants
|
|
Best Overall Response (BOR)
Progressive disease
|
10 Participants
|
|
Best Overall Response (BOR)
Non-evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: Time of response up to 32 weeksPopulation: This outcome was not analyzed because the response rate was 0%.
To evaluate the duration of response as the time of objective response (CR or PR) to the time of disease progression or death, per RECIST v1.1 as assessed by BICR and the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Enrollment through 18 weeksPopulation: Evaluable Population
To evaluate patients disease control rate of CR, PR, or SD at 18 weeks, per RECIST v1.1 as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=31 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Disease Control Rate (DCR)
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 31 weeks.Population: ITT Population
To evaluate PFS as median time to disease progression per RECIST v1.1, or death, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Progression-Free Survival (PFS)
|
2.4 Months
Interval 1.4 to 4.2
|
SECONDARY outcome
Timeframe: Baseline and up to 70 weeksPopulation: ITT Population
To evaluate OS as median time to death by any cause.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Overall Survival (OS)
|
3.9 Months
Interval 2.8 to 4.9
|
SECONDARY outcome
Timeframe: Enrollment through 3 months, 6 months, and 12 monthsPopulation: ITT Population
To evaluate PFS as the percentage of patients who are progression-free at 3, 6, and 12 months per RECIST v1.1, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Progression-Free Survival (PFS)
3 months
|
44.77 Percentage of participants
Interval 28.97 to 59.38
|
|
Progression-Free Survival (PFS)
6 months
|
8.00 Percentage of participants
Interval 1.57 to 21.5
|
|
Progression-Free Survival (PFS)
12 months
|
NA Percentage of participants
The Kaplan-Meier estimates and corresponding 95% confidence interval (CI) for the Progression-Free Survival (PFS) Rates at Months 3, 6, and 12 are provided. Due to no subjects being progression-free by Month 12, the PFS rate and 95% CI at that timepoint are not estimable and shown as NA.
|
SECONDARY outcome
Timeframe: Enrollment through 3 months, 6 months, and 12 monthsPopulation: ITT Population
To evaluate OS as the percentage of patients surviving at 3, 6, and 12, months.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Overall Survival (OS)
3 months
|
64.12 Percentage of participants
Interval 47.65 to 76.61
|
|
Overall Survival (OS)
6 months
|
21.55 Percentage of participants
Interval 10.23 to 35.58
|
|
Overall Survival (OS)
12 months
|
10.77 Percentage of participants
Interval 3.44 to 22.91
|
SECONDARY outcome
Timeframe: Enrollment through 8 weeks and 16 weeksPopulation: Patients in the ITT population who had elevated CA19-9 at Baseline
To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks in patients who have elevated CA19-9 at baseline. Response was defined as ≥50% reduction in CA19-9.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=39 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Cancer Antigen (CA)19-9
8 weeks
|
5 Participants
|
|
Cancer Antigen (CA)19-9
16 weeks
|
3 Participants
|
SECONDARY outcome
Timeframe: Enrollment through 6 weeksPopulation: Patients in the ITT Population with measurable disease at baseline by FDG-PET evaluation
To assess tumor response based on changes in fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at 6 weeks per the EORTC criteria, as assessed by BICR.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=23 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria
Complete metabolic response
|
0 Participants
|
|
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria
Partial metabolic response
|
6 Participants
|
|
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria
Stable metabolic disease
|
9 Participants
|
|
Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria
Progressive metabolic disease
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 32 weeksPopulation: ITT Population
To evaluate TTP as median time to disease progression per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Relacorilant With Nab-paclitaxel
n=43 Participants
Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Time to Progression (TTP)
|
4.2 Months
Interval 1.6 to
The upper 95% confidence interval of median TTP was not calculable due to insufficient number of patients with events.
|
Adverse Events
Relacorilant With Nab-paclitaxel
Serious adverse events
| Measure |
Relacorilant With Nab-paclitaxel
n=43 participants at risk
Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant is supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Cardiac disorders
Atrial Fibrillation
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Cardiac disorders
Atrial flutter
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Ascites
|
4.7%
2/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Obstruction gastric
|
4.7%
2/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
General disorders
Fatigue
|
4.7%
2/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
General disorders
Pyrexia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Infections and infestations
Sepsis
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Infections and infestations
Bacteraemia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Product Issues
Device occlusion
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
14.0%
6/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
Other adverse events
| Measure |
Relacorilant With Nab-paclitaxel
n=43 participants at risk
Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant, 100 mg and 25 mg: Relacorilant is supplied as capsules for oral dosing.
Nab-paclitaxel: Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.2%
13/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.6%
8/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Cardiac disorders
Tachycardia
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Nausea
|
48.8%
21/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
32.6%
14/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
23.3%
10/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
20.9%
9/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Ascites
|
16.3%
7/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Constipation
|
16.3%
7/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Abdominal distension
|
14.0%
6/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
General disorders
Fatigue
|
79.1%
34/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
General disorders
Oedema peripheral
|
20.9%
9/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
General disorders
Mucosal inflammation
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Neutrophil count decreased
|
27.9%
12/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
White blood cell count decreased
|
20.9%
9/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Platelet count decreased
|
18.6%
8/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Weight decreased
|
16.3%
7/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Blood alkaline phosphatase increased
|
11.6%
5/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Blood bilirubin increased
|
11.6%
5/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Investigations
Lymphocyte count decreased
|
11.6%
5/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.5%
17/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
27.9%
12/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.3%
10/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.9%
9/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.0%
6/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.6%
11/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Nervous system disorders
Neuropathy peripheral
|
16.3%
7/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Nervous system disorders
Dizziness
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Psychiatric disorders
Anxiety
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Psychiatric disorders
Confusional state
|
7.0%
3/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.3%
7/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.3%
4/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.6%
5/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
|
Vascular disorders
Hypotension
|
14.0%
6/43 • Up to 30 days after the last dose of study treatment (up to 73 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual publications will be allowed before publication of the multicenter results except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher. The Sponsor will comply with the requirements for publication of study results and determination of authorship in accordance with standard editorial and ethical practice and with the International Committee of Medical Journal Editors requirements.
- Publication restrictions are in place
Restriction type: OTHER