Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

August 30, 2023 updated by: University of Michigan Rogel Cancer Center

Phase II Multi-Center Trial of 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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

Olaparib taken by mouth twice daily
Trabectedin administered intravenously (IV) every 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6 months
Progression free survival
Time Frame: 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.
At approximately 2 years after enrollment
Overall survival
Time Frame: 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.
At approximately 2 years after enrollment
Incidence of adverse events
Time Frame: 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.
Up to 30 days after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rashmi Chugh, M.D., University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Actual)

January 30, 2023

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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