Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04076579
Phase
PHASE2
Status
Completed

Conditions

  • Sarcoma
  • Sarcoma Metastatic

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib taken by mouth twice daily
  • Trabectedin — DRUG
    Trabectedin administered intravenously (IV) every 21 days

Study Details

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.

Key Dates

Start date
Mar 17, 2020
Status verified
Aug 2025
Primary completion
Jan 30, 2023
Completion
Sep 26, 2024

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib + Trabectedin
    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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-

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By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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