NCT04076579CompletedPhase 2
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 · Last updated 29 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 29 Aug 2019
- Start date
- 17 Mar 2020
- Primary completion date
- 30 Jan 2023
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04076579
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 29
- From 17 Mar 2020 to the primary completion date, 30 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with PARP inhibitor, including olaparib
- Prior therapy with trabectedin
Other illness
- Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
- Known hypersensitivity to trabectedin or olaparib
Other
- Pregnant or breastfeeding women
- Other exclusions per protocol
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.