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Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

NCT04076579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-29

Study results available
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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 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

  • Sarcoma
  • Sarcoma Metastatic

Interventions

DRUG

Olaparib

Olaparib taken by mouth twice daily

DRUG

Trabectedin

Trabectedin administered intravenously (IV) every 21 days

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Rashmi Chugh, M.D. · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-17
Primary Completion
2023-01-30
Completion
2024-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04076579 on ClinicalTrials.gov