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PARP inhibitor
Olaparib + Temozolomide for Uterine Leiomyosarcoma
Phase 2 & 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial compares using a PARP inhibitor and alkylating agent to usual treatment for advanced uterine leiomyosarcoma after chemotherapy. The combo may be more effective.
Who is the study for?
This trial is for adults with advanced uterine leiomyosarcoma that has worsened after at least two prior treatments, including an anthracycline. Participants must have no major organ dysfunction, not be pregnant or breastfeeding, and cannot have had certain other cancers or severe illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial compares a new combination of drugs (Olaparib and Temozolomide) against standard treatments (Trabectedin and Pazopanib) to see if they are more effective in shrinking or stabilizing this type of cancer after previous chemotherapy has failed.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, and potential allergic reactions. The severity can vary from mild to serious.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS) (Phase III)
Progression free survival (PFS) (Phase II)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of adverse events
+1 moreOther outcome measures
Proportion of patients with a genomic alteration in a homologous recombination (HR) pathway gene
Relationship between the presence of an alteration in HR pathway genes and clinical benefit from olaparib and temozolomide
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 (olaparib, temozolomide)Experimental Treatment2 Interventions
Patients receive temozolomide is administered at PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
Group II: Arm 2 (trabectedin, pazopanib)Active Control2 Interventions
Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle and pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2210
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,331 Total Patients Enrolled
4 Trials studying Uterine Leiomyosarcoma
271 Patients Enrolled for Uterine Leiomyosarcoma
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,556 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my cancer treatment less than 28 days ago.I do not have any ongoing issues with perforations, abscesses, or fistulas.My advanced uLMS has not improved or I couldn't tolerate two previous treatments, including an anthracycline.I can take pills by mouth.I have been diagnosed with MDS or AML.I have previously taken specific medications for my condition.I am willing to have a central venous catheter placed if needed for my treatment.I have not had major surgery in the last 28 days.I have a history of heart problems.My blood pressure is not controlled by medication.I am not taking any strong medications that affect liver enzymes.I am a woman who can have children and my pregnancy test is negative.My cancer has spread and cannot be removed with surgery.I am 18 years old or older.I can take care of myself and perform daily activities.I have recovered from side effects of my previous cancer treatment.My cancer is a type of uterine sarcoma confirmed by tissue analysis.I have not had a recent heart attack or uncontrolled heart rhythm problems.I have previously been treated with trabectedin or pazopanib.My cancer has spread and cannot be removed with surgery, according to my doctor.I do not have any uncontrolled illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (olaparib, temozolomide)
- Group 2: Arm 2 (trabectedin, pazopanib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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