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NCT02397083 · ClinicalTrials.gov registry record · Phase 2

Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer

A Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 2
Development phase
102
Enrollment target
18
Study locations

NCT02397083 is a Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 102 participants, below the 192-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (47% lower). The trial reports 18 study locations across 9 states.

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The verdict

NCT02397083, a Phase 2 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
102 participants
Enrollment target
18
Study locations

Study Summary

This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Everolimus
  • DEVICE Levonorgestrel-Releasing Intrauterine System

Study Locations (18)

Texas

  • MD Anderson in The Woodlands - Conroe
  • Memorial Hermann Memorial City Medical Center - Houston
  • Lyndon Baines Johnson General Hospital - Houston
  • M D Anderson Cancer Center - Houston
  • The Woman's Hospital of Texas - Houston
  • MD Anderson West Houston - Houston
  • MD Anderson League City - League City
  • MD Anderson in Sugar Land - Sugar Land

Colorado

  • North Colorado Medical Center - Greeley
  • McKee Medical Center - Loveland

New Jersey

  • Cooper Hospital University Medical Center - Camden
  • MD Anderson Cancer Center at Cooper-Voorhees - Voorhees Township

Hawaii

  • Queen's Medical Center - Honolulu

Michigan

  • Covenant HealthCare Mackinaw - Saginaw

New York

  • Northwell Health - New Hyde Park

Ohio

  • OhioHealth Mansfield Hospital - Mansfield

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2015-09-23
Est. Completion 2026-09-30
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT02397083

The ClinicalTrials.gov registry entry for NCT02397083 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (47% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02397083 reports 18 study locations spanning 9 distinct geographic areas - top geographies include Texas, Colorado, New Jersey.

Frequently Asked Questions

What is clinical trial NCT02397083 about?

NCT02397083 is a clinical study titled "Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer". This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releas...

What is the current status of trial NCT02397083?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2015-09-23. Estimated completion is 2026-09-30.

What conditions does trial NCT02397083 study?

This clinical trial studies the following conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Atypical Endometrial Hyperplasia.

What interventions are being tested in trial NCT02397083?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Everolimus (DRUG), Levonorgestrel-Releasing Intrauterine System (DEVICE).

Who is sponsoring clinical trial NCT02397083?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02397083 being conducted?

This trial has 18 study locations across Colorado, Hawaii, Michigan, New Jersey, New York. 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

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