Clinical trialNCT05432791Active, not recruitingPhase 2/PHASE3Interventional

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

SponsorNational Cancer Institute (NCI)Enrollment74Locally Advanced Uterine Corpus LeiomyosarcomaMetastatic Uterine Corpus LeiomyosarcomaStage III Uterine Corpus Leiomyosarcoma AJCC v8Stage IV Uterine Corpus Leiomyosarcoma AJCC v8Unresectable Uterine Corpus Leiomyosarcoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Matthew Ingham
Alliance for Clinical Trials in Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

145 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Centro Comprensivo de Cancer de Upr
San Juan, Puerto Rico

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Epic Care-Dublin
Dublin, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Epic Care Cyberknife Center
Walnut Creek, California, United States
Uchealth University of Colorado Hospital
Aurora, Colorado, United States
Memorial Hospital North
Colorado Springs, Colorado, United States
Uchealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Uchealth Greeley Hospital
Greeley, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Um Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Um Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Lewis Cancer and Research Pavilion at Saint Joseph'S/candler
Savannah, Georgia, United States
Saint Luke'S Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke'S Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke'S Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke'S Cancer Institute - Nampa
Nampa, Idaho, United States

105 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Olaparib →Pazopanib →Temozolomide →Trabectedin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Mar 2023
Primary completion: 13 Aug 2024
Completion: 30 Jan 2027
Last update posted: 3 Aug 2026
Registered enrollment: 74
Registry id: NCT05432791

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.