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AKT Inhibitor
Ipatasertib + Megestrol Acetate for Endometrial Cancer
Phase 1 & 2
Recruiting
Led By Michaela O Grinsfelder
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests if a combination of drugs can help treat endometrial cancer more effectively than one drug alone.
Who is the study for?
This trial is for adults with grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer. Participants can have had any number of prior treatments but must not have received hormonal therapy within the last 6 months. They should be able to take oral medication, have no severe liver disease, uncontrolled diabetes, significant heart issues, active infections requiring IV antibiotics, and agree to use contraception if they can bear children.Check my eligibility
What is being tested?
The trial is testing whether adding Ipatasertib to Megestrol Acetate improves treatment outcomes in patients with advanced endometrial cancer. Ipatasertib blocks enzymes that may help tumor cells grow while Megestrol Acetate lowers estrogen levels which some tumor cells need to grow. The study will determine the safety and optimal doses as well as compare effectiveness against using Megestrol alone.See study design
What are the potential side effects?
Possible side effects include digestive issues due to both drugs' impact on hormone levels and gastrointestinal absorption; increased blood sugar levels; potential liver problems; fatigue from immune system impacts; and risks associated with taking pills that might affect other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of AEs (Phase II)
Incidence of adverse events (AEs) (Phase Ib)
Maximum tolerated dose for phase II (Phase Ib)
+1 moreSecondary outcome measures
Biomarkers (Phase II)
Objective response rate (ORR) (Phase II)
Pharmacokinetics of ipatasertib + megestrol acetate (Phase Ib)
Other outcome measures
pS6/total S6 and pPRAS40/total PRAS40 expression (Phase II)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase Ib (megestrol acetate, ipatasertib)Experimental Treatment5 Interventions
Patients receive megestrol acetate PO QD on days 1-28 and ipatasertib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial.
Group II: Phase II (megestrol acetate, ipatasertib)Experimental Treatment5 Interventions
Arm II: Patients receive megestrol acetate PO QD on days 1-28 and ipatasertib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial.
Group III: Phase II (megestrol acetate)Active Control4 Interventions
Arm I: Patients receive megestrol acetate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI during screening, on study, and during follow-up. Patients also undergo collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2011
Completed Phase 3
~2320
Computed Tomography
2017
Completed Phase 2
~2720
Megestrol Acetate
2007
Completed Phase 3
~540
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
231 Previous Clinical Trials
100,756 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,545 Total Patients Enrolled
Michaela O GrinsfelderPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently on IV antibiotics for an infection.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I have completed any hormonal cancer treatments at least 6 months ago.I have not been treated with AKT inhibitors before, but may have had PI3K or mTOR inhibitors.I am not pregnant and not nursing, or I am willing to stop nursing.I can take care of myself and perform daily activities.My endometrial cancer is grade 1 or 2 and has come back or spread.I am 18 years old or older.My brain scans show no worsening after treatment for brain metastases.My cholesterol or triglyceride levels are above 300 mg/dL and not under control.I have a significant liver condition, such as hepatitis, cirrhosis, or a history of heavy alcohol or drug use.I can take pills and don’t have stomach issues that affect medication absorption.I have another cancer type, but it won't affect this trial's treatment.I have a history of inflammatory bowel disease or currently have active bowel inflammation.I have a tumor or lymph node that can be measured and meets the size requirements.I do not have severe lung conditions or recent serious lung infections.My kidney function, measured by GFR, is normal or above 60.I haven't taken strong medication that affects drug metabolism in the last 14 days or longer.I take more than 10 mg of prednisone daily for a chronic condition.I have diabetes that is not well-controlled, indicated by high blood sugar or HbA1c levels.I have HIV, HBV, or HCV but it's under control or cured.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II (megestrol acetate, ipatasertib)
- Group 2: Phase Ib (megestrol acetate, ipatasertib)
- Group 3: Phase II (megestrol acetate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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