Clinical trial · Interventional
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib | Drug | Olaparib | ALIAS |
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Olaparib + Trabectedin
- description
- There are 2 cohorts. Both cohorts receive the same treatment: * Cohort 1: Leiomyosarcoma and liposarcoma * Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months.
- interventionNames
- Drug: Olaparib
- Drug: Trabectedin
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to 2 years
- description
- Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.
Secondary outcomes (4)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Key Inclusion Criteria * Age ≥ 16 years * Advanced unresectable or metastatic sarcoma * Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS) * Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors) * Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline. * Measurable disease by RECIST 1.1 * Adequate hematologic, renal, hepatic function * Adequate creatine phosphokinase * ECOG performance status ≤ 1 * Left ventricular ejection fraction (LVEF) \>= institutional lower limit of normal (LLN) * Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment Key Exclusion Criteria * Prior therapy with PARP inhibitor, including olaparib * Prior therapy with trabectedin * Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years * Pregnant or breastfeeding women * Known hypersensitivity to trabectedin or olaparib * Other exclusions per protocol
References
Publications (0)
Data not yet available