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NCT03880019 · ClinicalTrials.gov registry record · Phase 2
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
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
- 23
- Enrollment target
- 15
- Study locations
NCT03880019: Active 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).
NCT03880019 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 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03880019, 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
- 23 participants
- Enrollment target
- 15
- Study locations
Study Summary
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.
Primary Outcome
Will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria assessed by MRI: Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm); Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. A response rate of 10% is considered inactive and unworthy of further
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Olaparib
- DRUG Temozolomide
- PROCEDURE Core Biopsy
Study Locations (15)
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
- Mayo Clinic in Florida - Jacksonville
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
California
- Stanford Cancer Institute Palo Alto - Palo Alto
Colorado
- UCHealth University of Colorado Hospital - Aurora
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2026-11-12 |
| Phase | Phase 2 |
What the registry record for NCT03880019 still lists
NCT03880019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Stage III Uterine Corpus Leiomyosarcoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03880019 lists 15 locations in 12 states (Florida, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT03880019 about?
NCT03880019 is a clinical study titled "A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma". 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 bod...
What is the current status of trial NCT03880019?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2019-08-19. Estimated completion is 2026-11-12.
What conditions does trial NCT03880019 study?
This clinical trial studies the following conditions: Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, Uterine Corpus Leiomyosarcoma.
What interventions are being tested in trial NCT03880019?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Olaparib (DRUG), Temozolomide (DRUG), Core Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03880019?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03880019 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03880019's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
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-
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
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