Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Phase 2

Active, not recruiting

• Conditions: Sarcoma; Sarcoma Metastatic
• Interventions: Drug: Olaparib; Drug: Trabectedin

• Registration Number: NCT04076579
• Lead Sponsor: University of Michigan Rogel Cancer Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-09-03
• Study Start: 2020-03-17
• Primary Completion: 2023-01-30
• Results First Submitted: 2024-03-18
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Results First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olaparib + Trabectedin	Olaparib	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.
Olaparib + Trabectedin	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 Measures

Name	Time	Method
Overall Response Rate	Up to 2 years	Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	At approximately 2 years after enrollment	Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median and 6-month PFS will be estimated along with their 95% confidence intervals.
Overall Survival	At approximately 2 years after enrollment	Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS will be estimated along with their 95% confidence intervals.
Incidence of Adverse Events	Up to 30 days after end of treatment	The frequency and rates of adverse events occurring in at least 5% of participants and rates of grade 3-5 adverse events will be tabulated by system organ class and preferred term using Common Terminology Criteria of Adverse Events (CTCAE), within each cohort.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States