Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06400251
Eligibility Criteria:
Inclusion Criteria:
* Patients must have met applicable eligibility criteria in the Master MATCH Protocol EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
* Patients must have an AKT mutation as determined via the MATCH Master Protocol
* Patients with breast cancer are excluded
* Patients with castration-resistant prostate cancer should maintain castrate levels of testosterone (i.e., with gonadotropin-releasing hormone (GnRH) agonists or through surgical castration). Patients are allowed to continue abiraterone acetate/prednisone with Ipatasertib if the patient just progressed on abiraterone acetate/prednisone
* Patients must not have known hypersensitivity to Ipatasertib or compounds of similar chemical or biologic composition
* Patients with known KRAS, NRAS, HRAS, or BRAF mutations are not eligible for this protocol, as these mutations may lead to limited response due to resistance
* Patients with diabetes or risk for hyperglycemia are eligible. Patients with diabetes mellitus should be on a stable dose of oral hypoglycemic agents for \>= 4 weeks and appropriate diet. Patients with diabetes mellitus may enter the study unless any of the following exclusion criteria are fulfilled:
* Baseline fasting glucose value of \> 8.9 mmol/L or 160 mg/dL (fasting is defined as no calorific intake for at least 8 hours)
* Patients not on a stable dose of oral hypoglycemic medication for \>= 4 weeks and appropriate diet
* Insulin required for routine diabetic management and control
* More than two oral hypoglycemic medications required for routine diabetic management and control
* Glycosylated hemoglobin (hemoglobin A1C) \>= 7.5%
* Prior PI3K and mTOR inhibitors are allowed, including in the metastatic setting. Prior AKT inhibitors are excluded
* Patients with a history of inflammatory bowel diseases (Crohn's disease and ulcerative colitis) or active diverticulitis are not eligible
* Patients may not have received strong inhibitors or potent inducers or substrates of CYP3A4/5 within 2 weeks before the first dose of study treatment (3 weeks for St John's wort)
* In addition to the patient contraception requirements outlined in EAY131 MATCH Master Protocol, male patients must also refrain from donating sperm for the duration of study participation, and for 4 months after completion of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06400251
Study Brief:
Protocol Section:
NCT06400251