Trial Outcomes & Findings for Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors (NCT NCT00070109)
NCT ID: NCT00070109
Last Updated: 2018-09-14
Results Overview
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.
Results posted on
2018-09-14
Participant Flow
Participant milestones
| Measure |
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.
trabectedin: Given IV
pharmacological study: Correlative studies
|
Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
8
|
20
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
8
|
20
|
8
|
Reasons for withdrawal
| Measure |
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.
trabectedin: Given IV
pharmacological study: Correlative studies
|
Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
4
|
5
|
15
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
4
|
2
|
|
Overall Study
removed from prot thpy prior to chemo
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
Baseline characteristics by cohort
| Measure |
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients
n=8 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
pharmacological study: Correlative studies
|
Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients
n=6 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma
n=8 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma
n=20 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
n=8 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
18.5 years
n=5 Participants
|
15.5 years
n=7 Participants
|
16 years
n=5 Participants
|
14.5 years
n=4 Participants
|
16 years
n=21 Participants
|
15.5 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
38 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
8 participants
n=21 Participants
|
43 participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
7 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.Population: No pts in Group 1 were evaluated for response. 1 pt in Group 3 is excluded because the pt was removed from protocol therapy after cycle 3 when a cardiac evaluation was missed. The pt was removed prior to disease assessment on protocol therapy. 1 pt enrolled in Group 4 was excluded because patient was removed from therapy prior to chemotherapy.
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=6 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=7 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
n=19 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
n=8 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Response (Complete Response [CR] and Partial Response [PR])
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1 CyclePopulation: Two pts in Group 1 and 1 pt in Group 2 were excluded because they were removed from therapy prior to the DLT evaluation period and no DLT had been observed. No patients in Groups 3, 4, or 5 were evaluated for DLT.
Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of \> 7 days duration or Grade 4 thrombocytopenia of \> 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=6 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=5 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Number of Patients With Dose-Limiting Toxicity (DLT)
|
1 participants
|
0 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline up to168 hours after trabectedin infusion in course 1Population: Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate maximum plasma concentration of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=3 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
n=5 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin
|
3.643333333 ng/mL
Standard Deviation 4.08
|
2.285 ng/mL
Standard Deviation 0.191
|
1.889 ng/mL
Standard Deviation 1.26
|
—
|
PRIMARY outcome
Timeframe: From baseline up to168 hours after trabectedin infusion in course 1Population: Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate apparent volume at steady state of trabectedin of trabectedin. Group 1 and group 2 patients were excluded due to not submitting specimens.
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=3 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin
|
1860.666667 L
Standard Deviation 999.9
|
1340.5 L
Standard Deviation 439
|
3269.5 L
Standard Deviation 269.4
|
—
|
PRIMARY outcome
Timeframe: From baseline up to168 hours after trabectedin infusion in course 1Population: Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin half life. Group 1 and group 2 patients were excluded due to not submitting specimens.
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=3 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin
|
47.4 hours
Standard Deviation 17.0
|
49.5 hours
Standard Deviation 1.70
|
63.4 hours
Standard Deviation 22.4
|
—
|
PRIMARY outcome
Timeframe: From baseline up to168 hours after trabectedin infusion in course 1Population: Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin AUC. Group 1 and group 2 patients were excluded due to not submitting specimens.
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=3 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin
|
184.9 ng/(mLxh)
Standard Deviation 193
|
75.7 ng/(mLxh)
Standard Deviation 43.3
|
41.2 ng/(mLxh)
Standard Deviation 18.7
|
—
|
PRIMARY outcome
Timeframe: From baseline up to168 hours after trabectedin infusion in course 1Population: Patients for whom specimens were submitted to the pharmacokinetics laboratory with sufficient samples to calculate trabectedin clearance. Group 1 and group 2 patients were excluded due to not submitting specimens.
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
Outcome measures
| Measure |
Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2)
n=3 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4)
n=2 Participants
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5)
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|
|
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin
|
20.5786891 L/hr
Standard Deviation 17.9
|
18.11833775 L/hr
Standard Deviation 3.32
|
63.8304367 L/hr
Standard Deviation 29.7
|
—
|
Adverse Events
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients
n=8 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
pharmacological study: Correlative studies
|
Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients
n=6 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma
n=8 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma
n=19 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
n=8 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
10.5%
2/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
General disorders
Death NOS
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
General disorders
Fever
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
GGT increased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
Other adverse events
| Measure |
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients
n=8 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
pharmacological study: Correlative studies
|
Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients
n=6 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma
n=8 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma
n=19 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
n=8 participants at risk
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
trabectedin: Given IV
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
50.0%
3/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
47.4%
9/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
4/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
33.3%
2/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
26.3%
5/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
10.5%
2/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
50.0%
3/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
31.6%
6/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Eye disorders
Blurred vision
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
CPK increased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
10.5%
2/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
General disorders
Fatigue
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
General disorders
Fever
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
GGT increased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
26.3%
5/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
15.8%
3/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
21.1%
4/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
21.1%
4/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Neutrophil count decreased
|
50.0%
4/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
33.3%
2/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
52.6%
10/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
General disorders
Pain
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
26.3%
5/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
21.1%
4/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Investigations
White blood cell decreased
|
37.5%
3/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
16.7%
1/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
47.4%
9/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
25.0%
2/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/6
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
12.5%
1/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
5.3%
1/19
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
0.00%
0/8
1 patient in Group 4 was not included in the AE analysis as the patient never received treatment.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 352-273-0558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER