Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

NCT04076579 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: UMCC 2018.132HUM00161251
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

  Up to 2 years

Secondary Outcomes (4)

• Progression Free Survival

  At 6 months

• Progression Free Survival

  At 1 year after enrollment

• Overall Survival

  At 2 years after enrollment

• Incidence of Adverse Events

  Up to 30 days after end of treatment, and average of 4.5 months

Study Arms (1)

Olaparib + Trabectedin

EXPERIMENTAL

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.

Drug: Olaparib; Drug: Trabectedin

Interventions

Olaparib DRUG

Olaparib taken by mouth twice daily

Olaparib + Trabectedin

Trabectedin DRUG

Trabectedin administered intravenously (IV) every 21 days

Olaparib + Trabectedin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Janssen Scientific Affairs, LLC: collaborator
• AstraZeneca: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

olaparib; Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Clinical Trials Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Rashmi Chugh, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: March 17, 2020
• Primary Completion: January 30, 2023
• Study Completion: September 26, 2024
• Last Updated: August 29, 2025
• Results First Posted: July 29, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)