Phase 2
Completed N=29
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
Liposarcoma,Myxoid
Source: ClinicalTrials.gov NCT00579501 ↗
Enrolled (actual)
29
Serious AEs
20.7%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants With Pathological Complete Response (pCR) — 13 percentage of participants
Summary
The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Response (pCR) |
13 | — |
| SECONDARY Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) |
24.1 | — |
Eligibility Criteria
Inclusion Criteria
- Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
- Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
- Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])
- No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Exclusion Criteria
- Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone
- Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods
- History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
- Known distant metastases
- Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
Data sourced from ClinicalTrials.gov (NCT00579501). 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. Informational only — not medical advice.