29 Participants Needed

Trabectedin + Olaparib for Sarcoma

Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

RC

Rashmi Chugh, M.D.

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Adequate creatine phosphokinase
I am 16 years old or older.
Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN)
See 8 more

Exclusion Criteria

Other exclusions per protocol
Pregnant or breastfeeding women
I have been treated with trabectedin before.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trabectedin and olaparib in 21-day cycles for a maximum of 18 months

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Olaparib
  • Trabectedin
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Olaparib + TrabectedinExperimental Treatment2 Interventions

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Lynparza for:
🇺🇸
Approved in United States as Lynparza for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials
165
Recruited
579,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security