drugset / Trial / NCT03310541

AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations

NCT03310541

Phase 1 Completed 12 enrolled Memorial Sloan Kettering Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-10-11
Primary completion
2023-05-03
Completion
2023-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Capivasertib Small molecule 400 mg Oral
Subject Capivasertib Small molecule 480 mg Oral
Background 500mg IM days 1, 15, 29 (cycle 2 day 1) and then every 4 weeks Unknown 500 mg Intramuscular
Background Enzalutamide Other / unclassified 160 mg Oral