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ACTIVE NOT RECRUITING Phase 2

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

NCT03880019 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 23 participants
Start Date 2019-08-19
Est. Completion 2026-11-12
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03880019

The ClinicalTrials.gov registry entry for NCT03880019 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03880019 reports 15 study locations spanning 12 distinct geographic areas — top geographies include Florida, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03880019?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial