Status:
COMPLETED
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
AstraZeneca
Conditions:
Sarcoma
Sarcoma Metastatic
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
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 chemothe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04076579
Start Date
March 17 2020
End Date
September 26 2024
Last Update
August 29 2025
Active Locations (1)
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1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109