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NCT05538897 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers

A Phase 1 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
96
Enrollment target
20
Study locations

NCT05538897 is a Phase 1 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, below the 193-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT05538897, a Phase 1 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
96 participants
Enrollment target
20
Study locations

Study Summary

This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.

Conditions Studied

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma Recurrent Endometrial Endometrioid Adenocarcinoma Metastatic Endometrial Endometrioid Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Ipatasertib
  • PROCEDURE Magnetic Resonance Imaging
  • DRUG Megestrol Acetate

Study Locations (20)

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville
  • Sarasota Memorial Hospital-Venice - N. Venice
  • Florida Cancer Specialists - Sarasota Downtown - Sarasota
  • First Physicians Group-Sarasota - Sarasota
  • Sarasota Memorial Hospital - Sarasota
  • Florida Cancer Specialists - Venice Pinebrook - Venice

Idaho

  • Saint Alphonsus Cancer Care Center-Boise - Boise
  • Saint Luke's Cancer Institute - Boise - Boise
  • Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
  • Kootenai Health - Coeur d'Alene - Coeur d'Alene
  • Saint Luke's Cancer Institute - Fruitland - Fruitland
  • Saint Luke's Cancer Institute - Meridian - Meridian

Arkansas

  • Highlands Oncology Group - Fayetteville - Fayetteville
  • Highlands Oncology Group - Rogers - Rogers
  • Highlands Oncology Group - Springdale

Arizona

  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson

California

  • University of California Davis Comprehensive Cancer Center - Sacramento

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Georgia

  • Augusta University Medical Center - Augusta

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2023-03-31
Est. Completion 2027-01-31
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT05538897

The ClinicalTrials.gov registry entry for NCT05538897 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (50% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05538897 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Idaho, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05538897 about?

NCT05538897 is a clinical study titled "Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers". This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasert...

What is the current status of trial NCT05538897?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2023-03-31. Estimated completion is 2027-01-31.

What conditions does trial NCT05538897 study?

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

What interventions are being tested in trial NCT05538897?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Ipatasertib (DRUG), Magnetic Resonance Imaging (PROCEDURE), Megestrol Acetate (DRUG).

Who is sponsoring clinical trial NCT05538897?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05538897 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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