NCT04076579

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Olaparib	Olaparib taken by mouth twice daily
DRUG	Trabectedin	Trabectedin administered intravenously (IV) every 21 days

Timeline

• Start date: 2020-03-17
• Primary completion: 2023-01-30
• Completion: 2024-09-26
• First posted: 2019-09-03
• Last updated: 2025-08-29
• Results posted: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study