Skip to main content
OpenTrials
Completed

NCT Number: NCT04076579

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Metastatic

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

Treatment and study plan

Olaparib

Drug

Olaparib taken by mouth twice daily

Trabectedin

Drug

Trabectedin administered intravenously (IV) every 21 days

Primary outcomes

  1. Overall Response Rate

    Time frame: 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 outcomes

  1. Progression Free Survival

    Time frame: At 6 months

    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.

  2. Progression Free Survival

    Time frame: At 1 year 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. reported as survival probability estimates

  3. Overall Survival

    Time frame: At 2 years after enrollment

    Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS probability estimates will be estimated along with their 95% confidence intervals.

  4. Incidence of Adverse Events

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

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • AstraZeneca
  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 3, 2019
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.