A Phase I Study of AZD8186 with and without Abiraterone Acetate in Men with Advanced Prostate Cancer

Full Title

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of AZD8186 in Patients with Advanced Castration-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and Patients with Known PTEN-deficient/mutated or PIK3CB mutated/amplified Advanced Solid Malignancies, as Monotherapy and in Combination with Abiraterone Acetate or AZD2014

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies and are called "castration-resistant" prostate cancer (CRPC).

In this study, researchers want to find the highest dose of the investigational drug AZD8186 that can be given safely in men with CRPC, and evaluate its use alone and in combination with abiraterone acetate. Abiraterone acetate is a drug used to treat CRPC. It works by blocking the production of cancer-fueling testosterone by inhibiting an enzyme called CYP17. It is given with prednisone.

Some CRPC tumors have mutated versions of a protein called PTEN or a gene called PIK3CB. AZD8186 may be active against tumors with abnormal PTEN and PIK3CB. All medications being assessed in this study are taken orally (by mouth).

Eligibility

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

  • Patients must have CRPC.
  • At least 2 weeks must pass between the completion of prior chemotherapy and 4 weeks since previous radiation therapy or hormonal therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dana Rathkopf at 646-422-4379.

Protocol

16-037

Phase

I

Investigator

Co-Investigators

Locations