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Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
NCT05538897 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05538897
The ClinicalTrials.gov registry entry for NCT05538897 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 96 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 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. 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: NCT05538897 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Idaho, Arkansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05538897?
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 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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