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New drug cocktail aims to fight rare uterine cancer after chemo fails

NCT ID NCT05432791

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether combining olaparib and temozolomide works better than standard drugs (trabectedin or pazopanib) for people with advanced uterine leiomyosarcoma that has spread or cannot be removed by surgery and has stopped responding to initial chemotherapy. About 74 participants will be randomly assigned to receive either the combo or the usual treatment. The goal is to see if the combo can slow cancer growth or improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
olaparib and temozolomide
What this could lead to
If this works, it could offer a new treatment option that shrinks or stabilizes advanced uterine leiomyosarcoma when standard chemotherapy has stopped working.
What could go wrong
This is a mid-stage trial with only 74 participants, so results may not apply to everyone. The combination may cause side effects like bone marrow suppression, and it might not work better than existing drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

74 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed leiomyosarcoma of uterine origin, as established by the site institutional practice for pathology confirmation for research studies when enrolling the patient on study. Central pathology review will not occur. * Metastatic or locally advanced and surgically unresectable disease, in the opinion of the treating investigator. * Patients must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria to be eligible for the study. * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Age \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status =\< 2. * Patients must have had prior progression on, or intolerance to, at least two prior lines of systemic therapy for advanced uLMS, one of which was an anthracycline (anthracycline monotherapy or combination). Adjuvant chemotherapy will qualify as a prior line of treatment. Endocrine treatment will not qualify as a prior line of treatment. * Patients may not have received prior treatment with any PARP inhibitor, temozolomide or dacarbazine (IV analogue of temozolomide). * Patients may not have had prior treatment with BOTH of the agents included on the investigator's choice arm: trabectedin AND pazopanib. If the patient has had prior treatment with one of these agents, they are eligible; however, they must be assigned to the other agent for investigator's choice. That is, patients who have received prior pazopanib must be assigned to trabectedin, and patients who have received prior trabectedin must be assigned to pazopanib. * Patients must have recovered to baseline or =\< grade 1 per CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy, with the exception of fatigue (which must be =\< grade 2), alopecia and/or endocrinopathies related to prior immunotherapy which are controlled with hormone replacement. * Patients must have completed all prior anti-cancer treatment, including radiation, \>= 28 days prior to registration. * Patients may have undergone major surgery (related or unrelated to their cancer diagnosis) \>= 28 days of registration. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within =\< 28 days prior to registration). * Platelet count \>= 100,000/mm\^3 (within =\< 28 days prior to registration). * Creatinine =\< 1.5 \* upper limit of normal (ULN) (within =\< 28 days prior to registration). * If creatinine \> 1.5 \* ULN, then creatinine clearance (CrCl) must be \> 50 mL/min, per Cockcroft-Gault method. * Hemoglobin \>= 9 g/dL (within =\< 28 days prior to registration). * No transfusions =\< 14 days before cycle 1 day 1 (C1D1). * Total bilirubin =\< 1.5 x ULN (within =\< 28 days prior to registration). * If documented Gilbert's: =\< 2.0 x ULN. * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =\< 3 x ULN (within =\< 28 days prior to registration). * Patients may not have uncontrolled hypertension defined as a blood pressure (BP) \> 150/90 on two consecutive assessments during the screening period. If a patient is found to have a BP \> 150/90 on two consecutive assessments during the screening period, the patient may be started on an anti-hypertensive regimen, and will be considered eligible if two subsequent measurements are performed and the BP is =\< 150/90. If BP is in range on the first measurement, no further measurements are needed. * Patients must demonstrate a QTcF (Fredericia formula) =\< 470 msec on an electrocardiography (EKG) performed during screening. This criterion applies only to patients who will receive pazopanib if randomized to Arm 2. Repeat EKG testing during the screening period is allowed. * Patients may not have an uncontrolled ventricular arrhythmia or recent (within 3 months) myocardial infarction. * In addition to the above, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible, patients should be class 2B or better. * Patients may not have a history of active or unresolved: perforation, abscess or fistula within 28 days prior to registration (either clinically or radiographically). * Patients must not have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or a history of bone marrow biopsy findings at any time consistent with MDS and/or AML. * For patients with evidence of chronic hepatitis B (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patients with central nervous system (CNS)/leptomeningeal disease must have undergone definitive treatment, have no evidence of CNS progression on follow-up imaging performed at least 4 weeks after the CNS-directed therapy is completed, and be off all steroids, in order to be eligible. * Patients must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any other condition that would limit compliance with study requirements. * Patients must be able to swallow oral medications. * Patients may not require concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. * Patients may not require concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. * In order to complete the mandatory patient-completed measure, participants must be able to speak and/or read English and Spanish. Non-English or non-Spanish readers may still participate in the study but are not required to complete the PRO-CTCAE side effect surveys. * For all patients, prior to randomization and as part of eligibility, the investigator must select the agent which the patient would receive if assigned to the investigator's choice arm, prior to randomization. The patient must meet all eligibility criteria for that agent during screening and prior to randomization. * Patients without central venous access must be willing to undergo placement of central venous access (i.e. port or peripherally inserted central catheter \[PICC\] line, per institutional practice) if assigned to the investigator's choice arm and if the investigator intends to treat the patient with trabectedin. The site must be able to place central venous access within 10 days of registration/randomization.

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Conditions

The condition(s) this trial relates to.

leiomyosarcoma of the corpus uteri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced uterine corpus leiomyosarcoma Metastatic uterine corpus leiomyosarcoma Stage III uterine corpus leiomyosarcoma ajcc V8 Stage IV uterine corpus leiomyosarcoma ajcc V8 Unresectable uterine corpus leiomyosarcoma

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508, United States

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009, United States

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017, United States

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007, United States

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528, United States

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401, United States

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938, United States

  • Carle at The Riverfront

    Danville, Illinois, 61832, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927, Puerto Rico

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • City of Hope at Irvine Lennar

    Irvine, California, 92618, United States

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015, United States

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503, United States

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085, United States

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • ECU Health Medical Center

    Greenville, North Carolina, 27834, United States

  • Epic Care Cyberknife Center

    Walnut Creek, California, 94597, United States

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608, United States

  • Epic Care-Dublin

    Dublin, California, 94568, United States

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503, United States

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124, United States

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    Vancouver, Washington, 98684, United States

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210, United States

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062, United States

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030, United States

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686, United States

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405, United States

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074, United States

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, United States

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, United States

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868, United States

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482, United States

  • Mary Greeley Medical Center

    Ames, Iowa, 50010, United States

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • McFarland Clinic - Ames

    Ames, Iowa, 50010, United States

  • McFarland Clinic - Boone

    Boone, Iowa, 50036, United States

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129, United States

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158, United States

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433, United States

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141, United States

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314, United States

  • Munson Medical Center

    Traverse City, Michigan, 49684, United States

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201, United States

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026, United States

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035, United States

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oncology Associates PC

    Omaha, Nebraska, 68114, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Our Lady of the Lake Medical Oncology

    Baton Rouge, Louisiana, 70817, United States

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416, United States

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524, United States

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910, United States

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712, United States

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619, United States

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642, United States

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687, United States

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital Care Center - Westerly

    Westerly, Rhode Island, 02891, United States

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033, United States

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830, United States

  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06902, United States

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105, United States

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418, United States

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790, United States

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503, United States

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444, United States

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631, United States

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909, United States

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011, United States

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • United Hospital

    Saint Paul, Minnesota, 55102, United States

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Michigan Health - West

    Wyoming, Michigan, 49519, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235, United States

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473, United States

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