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Trabectedin + Olaparib for Sarcoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 16 years old or older.I have been treated with trabectedin before.My sarcoma cannot be removed by surgery and has spread.I haven't had treatment for another cancer, except skin cancer, in the last 2 years.I am fully active and can carry on all my pre-disease activities without restriction.I have been diagnosed with Leiomyosarcoma or Liposarcoma.I am allergic to trabectedin or olaparib.My cancer is a type of sarcoma, but not in the stomach or intestines.I have previously been treated with a PARP inhibitor like olaparib.I have had at least one standard chemotherapy, including an anthracycline for cohort 1.My blood, kidney, and liver functions are all within normal ranges.
- Group 1: Olaparib + Trabectedin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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