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PARP Inhibitor

Trabectedin + Olaparib for Sarcoma

Phase 2

Waitlist Available

Led By Rashmi Chugh, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 16 years

Advanced unresectable or metastatic sarcoma

Must not have

Prior therapy with trabectedin

Known hypersensitivity to trabectedin or olaparib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well two drugs work to treat patients with sarcoma that has spread or can't be removed with surgery.

Who is the study for?

This trial is for adults and teens (16+) with advanced sarcoma that can't be surgically removed or has spread. Participants must have tried at least one chemotherapy, which for certain sarcomas includes an anthracycline. They need to have measurable disease, good heart function, and normal blood, kidney, and liver tests. Women who can bear children and men must use birth control during the study.

What is being tested?

The trial is testing a combination of two drugs: Trabectedin (a chemotherapy drug) and Olaparib (blocks cell repair), to see if they work together to stop tumor growth in patients with advanced sarcoma. It's a phase II study designed to assess how well these tumors respond when both drugs are given.

What are the potential side effects?

Trabectedin may cause fatigue, nausea, changes in blood counts leading to infection risk or bleeding problems; it might also affect liver function. Olaparib could lead to similar side effects like tiredness, stomach issues but also potential lung problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or older.

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My sarcoma cannot be removed by surgery and has spread.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have been diagnosed with Leiomyosarcoma or Liposarcoma.

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I have had at least one standard chemotherapy, including an anthracycline for cohort 1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with trabectedin before.

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I am allergic to trabectedin or olaparib.

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I have previously been treated with a PARP inhibitor like olaparib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Incidence of Adverse Events

Overall Survival

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Olaparib + TrabectedinExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Trabectedin

2005

Completed Phase 3

~2580