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Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
NCT05432791 · View on ClinicalTrials.gov ↗
Study Summary
This phase II/III trial compares the effect of the combination treatment with olaparib and temozolomide to trabectedin or pazopanib (two of the most common chemotherapy drugs used as usual approach) in patients with uterine leiomyosarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) after initial chemotherapy has stopped working. The usual approach is defined as care most people get for advanced uterine leiomyosarcoma. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Bone Scan
- PROCEDURE Multigated Acquisition Scan
Study Locations (20)
Colorado
- UCHealth University of Colorado Hospital — Aurora
- UCHealth Memorial Hospital Central — Colorado Springs
- Memorial Hospital North — Colorado Springs
- Poudre Valley Hospital — Fort Collins
- Cancer Care and Hematology-Fort Collins — Fort Collins
- UCHealth Greeley Hospital — Greeley
- Medical Center of the Rockies — Loveland
California
- City of Hope Comprehensive Cancer Center — Duarte
- Epic Care-Dublin — Dublin
- Epic Care Partners in Cancer Care — Emeryville
- City of Hope at Irvine Lennar — Irvine
- Contra Costa Regional Medical Center — Martinez
- Epic Care Cyberknife Center — Walnut Creek
Connecticut
- Smilow Cancer Hospital-Derby Care Center — Derby
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Alaska
- Alaska Women's Cancer Care — Anchorage
Arizona
- Mayo Clinic Hospital in Arizona — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2023-03-30 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05432791
The ClinicalTrials.gov registry entry for NCT05432791 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Stage III Uterine Corpus Leiomyosarcoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05432791 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Colorado, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05432791 about?
NCT05432791 is a clinical study titled "Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working". This phase II/III trial compares the effect of the combination treatment with olaparib and temozolomide to trabectedin or pazopanib (two of the most common chemotherapy drugs used as usual approach) in patients with uterine leiomyosarcoma that may have spread from where it first started to nearby ti...
What is the current status of trial NCT05432791?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2023-03-30. Estimated completion is 2027-01-30.
What conditions does trial NCT05432791 study?
This clinical trial studies the following conditions: Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, Locally Advanced Uterine Corpus Leiomyosarcoma, Metastatic Uterine Corpus Leiomyosarcoma, Unresectable Uterine Corpus Leiomyosarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05432791?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Multigated Acquisition Scan (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05432791?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05432791 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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