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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 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. The trial reports 20 study locations across 6 states.

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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.

Conditions Studied

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

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

FieldValue
Enrollment Target 73 participants
Start Date 2023-03-30
Est. Completion 2027-01-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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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, categorized as Phase 2. 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 3,257 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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