A Phase I Study of AZD5363 in Patients with Solid Tumors Who Have AKT1 and PIK3CA Mutations

Full Title

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies


In some cancers, there is a problem in the gene that produces a protein called AKT1, or in a related gene called PIK3CA. Blocking the action of AKT1 with a drug like the investigational drug AZD5363 may stop the cancer from growing.

The optimal dose of AZD5363 has already been identified. In this study, researchers want to further assess AZD5363 at this dose in patients with persistent advanced solid tumors that contain mutations in AKT1 or PIK3CA. AZD5363 is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a solid tumor that continues to grow despite treatment and contains a mutation in AKT1 or PIK3CA.
  • Patients must have recovered from the serious side effects of prior therapies.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Hyman at 646-888-4226.