ClinicalTrials.gov record
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
ClinicalTrials.gov ID: NCT05432791
Public ClinicalTrials.gov record NCT05432791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 2/3 Study of Olaparib Plus Temozolomide Versus Investigator's Choice for the Treatment of Patients With Advanced Uterine Leiomyosarcoma After Progression on Prior Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05432791
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Bone Scan Procedure
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Multigated Acquisition Scan Procedure
- Olaparib Drug
- Pazopanib Drug
- Temozolomide Drug
- Trabectedin Drug
- Transthoracic Echocardiography Test Procedure
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2023 (Actual)
- Primary completion
- Aug 13, 2024 (Actual)
- Completion
- Jan 30, 2027 (Estimated)
- Last update posted
- Oct 1, 2026
2023 – 2027
United States locations
- U.S. sites
- 144
- U.S. states
- 34
- U.S. cities
- 123
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | — |
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Epic Care-Dublin | Dublin | California | 94568 | — |
| Epic Care Partners in Cancer Care | Emeryville | California | 94608 | — |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | — |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | — |
| Epic Care Cyberknife Center | Walnut Creek | California | 94597 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | — |
| Memorial Hospital North | Colorado Springs | Colorado | 80920 | — |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | — |
| Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | 80528 | — |
| UCHealth Greeley Hospital | Greeley | Colorado | 80631 | — |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | — |
| Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut | 06418 | — |
| Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut | 06824 | — |
| Smilow Cancer Hospital Care Center at Glastonbury | Glastonbury | Connecticut | 06033 | — |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | — |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | 06437 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | 06473 | — |
| Smilow Cancer Hospital Care Center at Long Ridge | Stamford | Connecticut | 06902 | — |
| Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut | 06790 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | 06708 | — |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | 06385 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | — |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | — |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83687 | — |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Carle at The Riverfront | Danville | Illinois | 61832 | — |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | — |
| Mary Greeley Medical Center | Ames | Iowa | 50010 | — |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | — |
| McFarland Clinic - Boone | Boone | Iowa | 50036 | — |
| Heartland Oncology and Hematology LLP | Council Bluffs | Iowa | 51503 | — |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| McFarland Clinic - Trinity Cancer Center | Fort Dodge | Iowa | 50501 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| McFarland Clinic - Jefferson | Jefferson | Iowa | 50129 | — |
| McFarland Clinic - Marshalltown | Marshalltown | Iowa | 50158 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Our Lady of the Lake Medical Oncology | Baton Rouge | Louisiana | 70817 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| MaineHealth Maine Medical Center- Scarborough | Scarborough | Maine | 04074 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Beacon Kalamazoo Cancer Center | Kalamazoo | Michigan | 49009 | — |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | — |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | — |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | — |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC | Omaha | Nebraska | 68114 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Oncology Associates PC | Omaha | Nebraska | 68114 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| ECU Health Medical Center | Greenville | North Carolina | 27834 | — |
| UH Seidman Cancer Center at UH Avon Health Center | Avon | Ohio | 44011 | — |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | — |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | — |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | — |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | — |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | — |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | — |
| Smilow Cancer Hospital Care Center - Westerly | Westerly | Rhode Island | 02891 | — |
| Saint Joseph's/Candler - Bluffton Campus | Bluffton | South Carolina | 29910 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | — |
| Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Washington | 98684 | — |
| Legacy Salmon Creek Hospital | Vancouver | Washington | 98686 | — |
| Vandalia Health/CAMC Institute for Academic Medicine | Charleston | West Virginia | 25304 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Marshfield Medical Center - Minocqua | Minocqua | Wisconsin | 54548 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05432791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05432791 live on ClinicalTrials.gov.