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

Novartis

Status and phase

Terminated

Phase 1

Conditions

Prostatic Neoplasms

Treatments

Drug: CFG920

Study type

Interventional

Funder types

Industry

Identifiers

NCT01647789

2012-001961-33 (EudraCT Number)

CCFG920X2101

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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