Trabectedin + Olaparib for Sarcoma
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trabectedin and olaparib in 21-day cycles for a maximum of 18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Olaparib
- Trabectedin
Olaparib is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
AstraZeneca
Industry Sponsor
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
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
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University