This study will test the recommended dose of AZD5363 (recommended from a previous phase 1 study of the drug) in patients with specific AKT mutations. In patients who have ER positive breast cancer with an AKT mutation, they will also be receiving a standard breast cancer drug called fulvestrant that is given as an injection. In patients who have prostate cancer with an AKT mutation, they will also be receiving a standard prostate cancer drug called enzalutamide that is taken orally.
Name: AZD5363
Description: AZD5363 400mg PO twice daily for 4 days on, 3 days off, every weekType: DrugProstate, Previously treated with Enzalutamide ER+ Breast, Previously treated with Fulvestrant Advanced Solid Tumors
Name: Enzalutamide
Description: Enzalutamide 160 mg PO once dailyType: DrugProstate, Previously treated with Enzalutamide
Name: Fulvestrant
Description: 500mg IM days 1, 15, 29 (cycle 2 day 1) and then every 4 weeksType: DrugER+ Breast, Previously treated with Fulvestrant
Description: A response is defined as any of the following: a response according to RECIST v 1.1, PCWG3 (for patients with measurable visceral and/or nodal disease at baseline) or RANO as applicable or a reduction in the PSA level of 50% or more (for prostate cancer patients without visceral and/or nodal disease at baseline), with a confirmatory assessment at least 4 weeks later.
Measure: number of patients with an objective response rate (ORR) of AZD5363 Time: 1 yearAllocation: Non-Randomized
Parallel Assignment
There is one SNP
condoms) Exclusion Criteria: - ER+ breast cancer patients harboring the AKT1 E17K mutation (patient population tested in MSK IRB# 14-214, study D3610C00001 part E, ClinicalTrials.gov --- E17K ---