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NCT05432791 · ClinicalTrials.gov registry record · Phase 2
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
A Phase 2 study of Stage III Uterine Corpus Leiomyosarcoma AJCC v8 and Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
- 20
- Study locations
NCT05432791: Active Phase 2 study of Stage III Uterine Corpus Leiomyosarcoma AJCC v8 and Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT05432791 is a Phase 2 study of Stage III Uterine Corpus Leiomyosarcoma AJCC v8 and Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05432791, a Phase 2 study of Stage III Uterine Corpus Leiomyosarcoma AJCC v8 and Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. PFS rates at 1 year will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well.
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 |
What the registry record for NCT05432791 still lists
NCT05432791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
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.
NCT05432791 names 20 study sites across 6 states, led by Colorado, California, Connecticut.
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.
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).
Who is sponsoring clinical trial NCT05432791?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05432791's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
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Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
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