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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 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. The trial reports 15 study locations across 12 states.

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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.

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)

3,257 total trials

What the Registry Record Tells You About NCT03880019

The ClinicalTrials.gov registry entry for NCT03880019 describes a study currently listed as active not recruiting, categorized as Phase 2. 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 3,257 total studies on file at ClinicalTrials.gov.

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 reports 15 study locations spanning 12 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.