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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: Active Phase 1 study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine frequency and severity of adverse events for all dose combinations of megestrol acetate plus ipatasertib. Descriptive statistics will be used to summarize AEs. These analyses will focus on individuals who initiated their assigned treatment and will summarize maximum grade of AEs occurring during treatment classified by Common Toxicity Criteria (CTC) category. The primary summary of AEs will present counts and percentages, regardless of whether the AE was attributed to any of the stu
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-03-31 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
What the registry record for NCT05538897 still lists
NCT05538897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 193-participant average among 5 other FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma trials with a reported enrollment target (50% lower).
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 names 20 study sites across 7 states, led by 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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