Phase Ib (megestrol acetate, ipatasertib) for Endometrial Endometrioid Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Florida Health Science Center - Gainesville, Gainesville, FLEndometrial Endometrioid Adenocarcinoma+4 MoreComputed Tomography - Procedure
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial tests if a combination of drugs can help treat endometrial cancer more effectively than one drug alone.

Eligible Conditions
  • Recurrent Endometrial Endometrioid Adenocarcinoma
  • FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
  • Stage IV Uterine Cancer
  • Metastatic Endometrial Endometrioid Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Year 5
Progression free survival (PFS) (Phase II)
Day 8
Pharmacokinetics of ipatasertib + megestrol acetate (Phase Ib)
Up to 5 years
Biomarkers (Phase II)
Incidence of AEs (Phase II)
Incidence of adverse events (AEs) (Phase Ib)
Maximum tolerated dose for phase II (Phase Ib)
Objective response rate (ORR) (Phase II)
pS6/total S6 and pPRAS40/total PRAS40 expression (Phase II)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Phase II (megestrol acetate)
1 of 3
Phase Ib (megestrol acetate, ipatasertib)
1 of 3
Phase II (megestrol acetate, ipatasertib)
1 of 3

Active Control

Experimental Treatment

96 Total Participants · 3 Treatment Groups

Primary Treatment: Phase Ib (megestrol acetate, ipatasertib) · No Placebo Group · Phase 1 & 2

Phase Ib (megestrol acetate, ipatasertib)Experimental Group · 4 Interventions: Computed Tomography, Ipatasertib, Magnetic Resonance Imaging, Megestrol Acetate · Intervention Types: Procedure, Drug, Procedure, Drug
Phase II (megestrol acetate, ipatasertib)Experimental Group · 4 Interventions: Computed Tomography, Ipatasertib, Magnetic Resonance Imaging, Megestrol Acetate · Intervention Types: Procedure, Drug, Procedure, Drug
Phase II (megestrol acetate)ActiveComparator Group · 3 Interventions: Computed Tomography, Magnetic Resonance Imaging, Megestrol Acetate · Intervention Types: Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Ipatasertib
2011
Completed Phase 3
~1910
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Megestrol Acetate
2007
Completed Phase 3
~540

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,162 Previous Clinical Trials
41,167,198 Total Patients Enrolled
6 Trials studying Endometrial Endometrioid Adenocarcinoma
1,123 Patients Enrolled for Endometrial Endometrioid Adenocarcinoma
NRG OncologyOTHER
221 Previous Clinical Trials
95,764 Total Patients Enrolled
3 Trials studying Endometrial Endometrioid Adenocarcinoma
989 Patients Enrolled for Endometrial Endometrioid Adenocarcinoma
Michaela O GrinsfelderPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · Female Participants · 22 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate in the trial if you had another type of cancer in the past, but it will not affect the safety or effectiveness of the investigational treatment.

Frequently Asked Questions

What is the enrolment size of this study?

"Affirmative. According to clinicaltrials.gov, this clinical trial is still recruiting participants after first being advertised on January 13th 2023 and most recently edited on the 28th of that same month. This investigation requires 96 recruits from a single location." - Anonymous Online Contributor

Unverified Answer

Is there availability for prospective participants to join this investigation?

"Yes, according to clinicaltrials.gov this medical trial is actively enrolling participants at one location. It was first posted on 13th of January 2023 and the most recent update occurred 28 days later. 96 individuals need to be recruited for full completion of the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.