Phase 2
N=270
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Liposarcoma · Leiomyosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00060944 ↗Enrolled (actual)
270
Serious AEs
34.2%
Results posted
Sep 2014
Primary outcome: Primary: Time to Progression- Independent Review — 3.7; 2.3 months — p=0.0302
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Yondelis (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression- Independent Review |
3.7; 2.3 | 0.0302 sig |
| SECONDARY Percentage of Participants Objective Response - Independent Review |
5.1; 1.5 | — |
| SECONDARY Duration of Response - Independent Review |
7.5; NA | — |
| SECONDARY Progression-Free Survival - Independent Review |
3.3; 2.3 | 0.0418 sig |
| SECONDARY Overall Survival |
13.9; 11.8 | 0.1920 |
Summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
Eligibility Criteria
Inclusion Criteria
- Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
- Have a pathology specimen available for centralized review
- Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
- Have adequate bone marrow, liver and kidney function
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
- Cancer that has metastasized (spread) to the central nervous system
- Active viral hepatitis or chronic liver disease
- Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
- History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment
Data sourced from ClinicalTrials.gov (NCT00060944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.