A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer

A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer

This study was supposed to have assessed the safety and preliminary antitumor activity of CFG920, a new CYP17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant.

The study was terminated after Phase I (dose escalation phase) and Phase II part of the study was not initiated. Novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. As the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.

Inclusion Criteria:

• Confirmed diagnosis of castration resistant prostate cancer
• Documented metastases
• ECOG performance status 0 or 1
• Documented progression following the Prostate Cancer Working Group 2 guidelines
• Fresh or archived tumor sample

Exclusion Criteria:

• Impaired cardiac function
• Uncontrolled hypertension despire appropriate medical therapy
• History of pituitary or adrendal dysfunction
• Chronic steriod therapy other than daily use of 10mg prednisone
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral CFG920
• Brain metastases that have not been adequately treated
• Malignant disease other than that being treated in this study
• Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply