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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

Study 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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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 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 more
Other 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
13,743 Previous Clinical Trials
40,957,761 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

Media Library

Olaparib (PARP inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05633381 — Phase 2 & 3
Uterine Leiomyosarcoma Research Study Groups: Arm 1 (olaparib, temozolomide), Arm 2 (trabectedin, pazopanib)
Uterine Leiomyosarcoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT05633381 — Phase 2 & 3
Olaparib (PARP inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633381 — Phase 2 & 3
~47 spots leftby Mar 2030