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Active, not recruiting Phase 2 Interventional Results available

A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma

ClinicalTrials.gov ID: NCT03880019

Public ClinicalTrials.gov record NCT03880019. 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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 1:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study of the PARP Inhibitor Olaparib in Combination With the DNA Damaging Agent Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II trial studies olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that has spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with LMS.

Study identification

NCT ID
NCT03880019
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
23 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
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
Aug 19, 2019 (Actual)
Primary completion
Aug 1, 2020 (Actual)
Completion
Nov 12, 2026 (Estimated)
Last update posted
Jul 31, 2026

2019 – 2026

United States locations

U.S. sites
15
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Mayo Clinic Hospital in Arizona Phoenix Arizona 85054 —
Stanford Cancer Institute Palo Alto Palo Alto California 94304 —
UCHealth University of Colorado Hospital Aurora Colorado 80045 —
UF Health Cancer Institute - Gainesville Gainesville Florida 32610 —
Mayo Clinic in Florida Jacksonville Florida 32224-9980 —
Massachusetts General Hospital Cancer Center Boston Massachusetts 02114 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
Wayne State University/Karmanos Cancer Institute Detroit Michigan 48201 —
Weisberg Cancer Treatment Center Farmington Hills Michigan 48334 —
Mayo Clinic in Rochester Rochester Minnesota 55905 —
Washington University School of Medicine St Louis Missouri 63110 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 —
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03880019, 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 Jul 31, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03880019 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →