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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My cancer is a type of sarcoma, but not in the stomach or intestines.
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I have had at least one standard chemotherapy, including an anthracycline for cohort 1.
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My blood, kidney, and liver functions are all within normal ranges.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression free survival

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
~2140
Trabectedin
2005
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,238 Previous Clinical Trials
288,471,392 Total Patients Enrolled
9 Trials studying Sarcoma
588 Patients Enrolled for Sarcoma
University of Michigan Rogel Cancer CenterLead Sponsor
292 Previous Clinical Trials
24,088 Total Patients Enrolled
5 Trials studying Sarcoma
305 Patients Enrolled for Sarcoma
Janssen Scientific Affairs, LLCIndustry Sponsor
157 Previous Clinical Trials
579,643 Total Patients Enrolled
1 Trials studying Sarcoma
48 Patients Enrolled for Sarcoma

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04076579 — Phase 2
Sarcoma Research Study Groups: Olaparib + Trabectedin
Sarcoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04076579 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04076579 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research endeavor been undertaken previously?

"Since 2005, AstraZeneca has been researching Trabectedin. In the initial trial 98 patients were enrolled and Phase 1 drug approval was granted. Presently, there are 202 active studies involving this medication in 1486 cities across 60 nations."

Answered by AI

Has Trabectedin previously been investigated during a research study?

"Presently, 202 Trabectedin studies are in progress and 29 of those trials have entered Phase 3. These trials span 9427 sites around the world with most taking place in Houston, Texas."

Answered by AI

Does Trabectedin present any significant risks to users?

"According to our team at Power, Trabectedin's safety was rated a 2 on the 1-3 scale. This is because there are data that suggest its safety but none backing efficacy in this Phase 2 trial."

Answered by AI

What is the aggregate amount of participants enrolled in this trial?

"Indeed, the information present on clinicaltrials.gov reveals that this trial is still actively enrolling individuals. This investigation was first posted on March 17th 2020 and last updated on December 15th 2021; 53 patients must be recruited from a single location to complete it."

Answered by AI

Is this experiment still open for enrollment?

"Yes, the clinical trial is currently seeking participants. It was first listed on March 17th 2020 and has been amended most recently on December 15th 2021 according to information held at clinicaltrials.gov."

Answered by AI

What conditions is Trabectedin usually employed to address?

"Trabectedin is commonly used to address the symptoms of rna-binding protein fus. This medication can also aid with metastatic liposarcoma, pharmacotherapy, and primary peritoneal cancer treatment plans."

Answered by AI
~6 spots leftby Mar 2025