Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

NCT ID: NCT04076579

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-17
• Study Completion Date: 2024-09-26

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.

Conditions

Sarcoma; Sarcoma Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Olaparib

Intervention Type: DRUG

Olaparib taken by mouth twice daily

Trabectedin

Intervention Type: DRUG

Trabectedin administered intravenously (IV) every 21 days

Interventions

Olaparib

Olaparib taken by mouth twice daily

Intervention Type: DRUG

Trabectedin

Trabectedin administered intravenously (IV) every 21 days

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rashmi Chugh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00161251

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2018.132

Identifier Type: -

Identifier Source: org_study_id