Trial Outcomes & Findings for A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer (NCT NCT00060944)
NCT ID: NCT00060944
Last Updated: 2014-09-08
Results Overview
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
271 participants
Primary outcome timeframe
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Results posted on
2014-09-08
Participant Flow
This study evaluated the efficacy and safety of of trabectedin in participants with locally advanced or metastatic L-sarcoma whose disease had relapsed or become refractory after treatment with an anthracycline and ifosfamide. The study was conducted between 12 May 2003 and 23 April 2008 and recruited participants from 9 countries worldwide.
In this study 271 participants were enrolled of which 270 participants (134 in the Trabectedin 1.5 mg/m2 group and 136 in the Trabectedin 0.58 mg/m2 group) were randomized as 1 participant was enrolled twice. Of these, 260 participants were treated with trabectedin including 130 participants in each treatment group.
Participant milestones
| Measure |
Trabectedin 1.5 mg/m2
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
134
|
|
Overall Study
Treated
|
130
|
130
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
136
|
134
|
Reasons for withdrawal
| Measure |
Trabectedin 1.5 mg/m2
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
10
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
18
|
5
|
|
Overall Study
Disease Progression
|
93
|
94
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Subject Ineligible To Continue
|
2
|
1
|
|
Overall Study
Treatment Switch
|
0
|
13
|
|
Overall Study
Other
|
2
|
4
|
|
Overall Study
randomized but not treated
|
6
|
4
|
Baseline Characteristics
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Trabectedin 1.5 mg/m2
n=136 Participants
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=134 Participants
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
12 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States Of America
|
89 participants
n=5 Participants
|
92 participants
n=7 Participants
|
181 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 yearsPopulation: All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2
n=136 Participants
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=134 Participants
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Time to Progression- Independent Review
|
3.7 months
Interval 2.1 to 5.4
|
2.3 months
Interval 2.0 to 3.5
|
SECONDARY outcome
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 yearsPopulation: All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2
n=136 Participants
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=134 Participants
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Percentage of Participants Objective Response - Independent Review
|
5.1 Percentage of participants
Interval 2.1 to 10.3
|
1.5 Percentage of participants
Interval 0.2 to 5.3
|
SECONDARY outcome
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 yearsPopulation: All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed.
Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2
n=7 Participants
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=2 Participants
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Duration of Response - Independent Review
|
7.5 Months
Interval 6.1 to 7.8
|
NA Months
Interval 3.4 to
Median was not estimable as data was available for only 1 participant and second participant was censored.
|
SECONDARY outcome
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 yearsPopulation: All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2
n=136 Participants
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=134 Participants
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Progression-Free Survival - Independent Review
|
3.3 months
Interval 2.1 to 4.6
|
2.3 months
Interval 2.0 to 3.4
|
SECONDARY outcome
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 yearsPopulation: All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2
n=136 Participants
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=134 Participants
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Overall Survival
|
13.9 months
Interval 12.5 to 18.6
|
11.8 months
Interval 9.9 to 14.9
|
Adverse Events
Trabectedin 1.5 mg/m2
Serious events: 48 serious events
Other events: 129 other events
Deaths: 0 deaths
Trabectedin 0.58 mg/m2
Serious events: 41 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabectedin 1.5 mg/m2
n=130 participants at risk
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=130 participants at risk
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.77%
1/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.4%
7/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.77%
1/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
2.3%
3/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.77%
1/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.3%
3/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
3/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
General disorders
Chest Discomfort
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
General disorders
Chest Pain
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
General disorders
Extravasation
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
General disorders
Oedema
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
General disorders
Oedema Peripheral
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
General disorders
Organ Failure
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
General disorders
Pain
|
2.3%
3/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
General disorders
Pyrexia
|
3.8%
5/130 • 5 years
|
3.8%
5/130 • 5 years
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Infections and infestations
Bacteraemia
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Infections and infestations
Catheter Related Infection
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Infections and infestations
Empyema
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Infections and infestations
Infection
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Infections and infestations
Perineal Abscess
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Infections and infestations
Pneumonia
|
4.6%
6/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Infections and infestations
Sepsis
|
0.77%
1/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Infections and infestations
Septic Shock
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Infections and infestations
Urosepsis
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Infections and infestations
Wound Infection
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Injury, poisoning and procedural complications
Radiation Pneumonitis
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Investigations
Alanine Aminotransferase Increased
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Investigations
Blood Bilirubin Increased
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Investigations
Blood Creatinine Increased
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Investigations
Blood Urea Increased
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Investigations
Mediastinoscopy
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
1/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
3/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.77%
1/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma Metastatic
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Associated Fever
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Nervous system disorders
Nerve Compression
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Nervous system disorders
Paresis
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Psychiatric disorders
Suicide Attempt
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-Cardiogenic Pulmonary Oedema
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.77%
1/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
3/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.77%
1/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Abdominal Operation
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Bladder Catheterisation
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Hepatectomy
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Surgical and medical procedures
Hepatic Embolisation
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Laparotomy
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Surgical and medical procedures
Lung Operation
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Surgical and medical procedures
Mass Excision
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Surgical and medical procedures
Sarcoma Excision
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Spinal Laminectomy
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Therapeutic Embolisation
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Tumour Excision
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.8%
5/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Vascular disorders
Embolism
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Vascular disorders
Hypertension
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Vascular disorders
Hypotension
|
0.77%
1/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Vascular disorders
Shock
|
0.77%
1/130 • 5 years
|
0.00%
0/130 • 5 years
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/130 • 5 years
|
0.77%
1/130 • 5 years
|
|
Vascular disorders
Thrombosis
|
1.5%
2/130 • 5 years
|
0.00%
0/130 • 5 years
|
Other adverse events
| Measure |
Trabectedin 1.5 mg/m2
n=130 participants at risk
Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
|
Trabectedin 0.58 mg/m2
n=130 participants at risk
Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.3%
42/130 • 5 years
|
30.8%
40/130 • 5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.3%
16/130 • 5 years
|
6.9%
9/130 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
49.2%
64/130 • 5 years
|
27.7%
36/130 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.2%
25/130 • 5 years
|
7.7%
10/130 • 5 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.2%
8/130 • 5 years
|
7.7%
10/130 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.1%
17/130 • 5 years
|
20.0%
26/130 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.2%
8/130 • 5 years
|
3.1%
4/130 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
34.6%
45/130 • 5 years
|
34.6%
45/130 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
30/130 • 5 years
|
21.5%
28/130 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
8/130 • 5 years
|
9.2%
12/130 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
74.6%
97/130 • 5 years
|
54.6%
71/130 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
43.1%
56/130 • 5 years
|
26.2%
34/130 • 5 years
|
|
General disorders
Asthenia
|
20.0%
26/130 • 5 years
|
20.0%
26/130 • 5 years
|
|
General disorders
Chest Pain
|
4.6%
6/130 • 5 years
|
11.5%
15/130 • 5 years
|
|
General disorders
Chills
|
6.2%
8/130 • 5 years
|
3.8%
5/130 • 5 years
|
|
General disorders
Fatigue
|
58.5%
76/130 • 5 years
|
55.4%
72/130 • 5 years
|
|
General disorders
Oedema
|
3.1%
4/130 • 5 years
|
5.4%
7/130 • 5 years
|
|
General disorders
Oedema Peripheral
|
13.1%
17/130 • 5 years
|
14.6%
19/130 • 5 years
|
|
General disorders
Pain
|
6.2%
8/130 • 5 years
|
8.5%
11/130 • 5 years
|
|
General disorders
Pyrexia
|
23.8%
31/130 • 5 years
|
13.8%
18/130 • 5 years
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.3%
16/130 • 5 years
|
8.5%
11/130 • 5 years
|
|
Investigations
Alanine Aminotransferase Increased
|
54.6%
71/130 • 5 years
|
41.5%
54/130 • 5 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
47.7%
62/130 • 5 years
|
29.2%
38/130 • 5 years
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
30.0%
39/130 • 5 years
|
28.5%
37/130 • 5 years
|
|
Investigations
Blood Bilirubin Increased
|
10.8%
14/130 • 5 years
|
5.4%
7/130 • 5 years
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
10.8%
14/130 • 5 years
|
14.6%
19/130 • 5 years
|
|
Investigations
Blood Creatinine Increased
|
6.9%
9/130 • 5 years
|
4.6%
6/130 • 5 years
|
|
Investigations
Haemoglobin Decreased
|
6.9%
9/130 • 5 years
|
6.2%
8/130 • 5 years
|
|
Investigations
Neutrophil Count Decreased
|
12.3%
16/130 • 5 years
|
3.8%
5/130 • 5 years
|
|
Investigations
Platelet Count Decreased
|
5.4%
7/130 • 5 years
|
3.1%
4/130 • 5 years
|
|
Investigations
Transaminases Increased
|
5.4%
7/130 • 5 years
|
1.5%
2/130 • 5 years
|
|
Investigations
Weight Decreased
|
4.6%
6/130 • 5 years
|
6.2%
8/130 • 5 years
|
|
Investigations
White Blood Cell Count Decreased
|
8.5%
11/130 • 5 years
|
6.2%
8/130 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
22.3%
29/130 • 5 years
|
16.2%
21/130 • 5 years
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.5%
11/130 • 5 years
|
6.9%
9/130 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
9/130 • 5 years
|
5.4%
7/130 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
7/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.6%
6/130 • 5 years
|
6.9%
9/130 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.5%
11/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
13/130 • 5 years
|
5.4%
7/130 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
5/130 • 5 years
|
6.2%
8/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
17/130 • 5 years
|
12.3%
16/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.8%
18/130 • 5 years
|
19.2%
25/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
4.6%
6/130 • 5 years
|
6.2%
8/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.1%
17/130 • 5 years
|
11.5%
15/130 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.0%
13/130 • 5 years
|
11.5%
15/130 • 5 years
|
|
Nervous system disorders
Dizziness
|
13.8%
18/130 • 5 years
|
10.8%
14/130 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
10.0%
13/130 • 5 years
|
6.2%
8/130 • 5 years
|
|
Nervous system disorders
Headache
|
28.5%
37/130 • 5 years
|
26.9%
35/130 • 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
8/130 • 5 years
|
4.6%
6/130 • 5 years
|
|
Nervous system disorders
Paraesthesia
|
6.9%
9/130 • 5 years
|
4.6%
6/130 • 5 years
|
|
Psychiatric disorders
Anxiety
|
8.5%
11/130 • 5 years
|
6.9%
9/130 • 5 years
|
|
Psychiatric disorders
Depression
|
6.9%
9/130 • 5 years
|
6.9%
9/130 • 5 years
|
|
Psychiatric disorders
Insomnia
|
15.4%
20/130 • 5 years
|
13.1%
17/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.7%
23/130 • 5 years
|
16.9%
22/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.2%
21/130 • 5 years
|
26.2%
34/130 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.4%
7/130 • 5 years
|
4.6%
6/130 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
4/130 • 5 years
|
5.4%
7/130 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
9/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
7/130 • 5 years
|
2.3%
3/130 • 5 years
|
|
Vascular disorders
Hypotension
|
10.0%
13/130 • 5 years
|
1.5%
2/130 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60