Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Mege… (NCT05538897) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
United States96 participantsStarted 2023-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer
* Patients must have measurable disease according to RECIST version (v)1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or MRI. Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
* Patients may have received unlimited prior lines of therapy. If patient received prior hormonal therapy (e.g., megestrol acetate, medroxyprogesterone acetate, aromatase inhibitor, tamoxifen, fulvestrant) it must have completed at least 6 months prior to registration
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Platelets \>= 100,000/mcl within 14 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,500/mcl within 14 days prior to registration
* Hemoglobin \>= 9 g/dL within 14 days prior to registration
* Glomerular filtration rate (GFR) \>= 60 mL/min/1.73m\^2 measured using Cockcroft-Gault equation or the estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study within 14 days prior to registration
* Total bilirubin =\< 1.5 x the upper limit of normal (ULN) within 14 days …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1/2, which means it's still establishing safety as well as effectiveness — can you explain what that means for what's known and unknown about the risks of combining ipatasertib with megestrol acetate for my specific situation?
2The trial is listed as 'active not recruiting,' meaning they're no longer enrolling new patients — is there any way I could still access ipatasertib through a different trial, a compassionate use program, or another route you'd recommend?
3One of the main things this trial is measuring is progression-free survival in Phase 2 — based on what's been reported so far, how does that compare to what I might expect from standard treatments for recurrent or metastatic endometrial endometrioid cancer?
4Since the Phase 1 portion is focused on finding the maximum tolerated dose and tracking side effects of this drug combination, how would you weigh the potential benefit against the uncertainty of safety for someone at my stage of disease?
5My cancer is classified as FIGO Grade 1 or Grade 2 endometrioid — does my specific grade or the fact that it's recurrent versus metastatic affect whether this kind of hormonal plus AKT inhibitor approach would even be worth pursuing compared to other options you'd consider for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs) (Phase Ib)
Timeframe: Up to 5 years
2
Maximum tolerated dose for phase II (Phase Ib)
Timeframe: Up to 5 years
3
Progression free survival (PFS) (Phase II)
Timeframe: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years