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

Stopped early · Phase 1

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT01647789

Run by

Novartis Pharmaceuticals

People needed

31

Starts

2012-12-04

Expected to finish

2016-02-03

Last updated by the study team

2018-08-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Medical Center Dept of Oncology — San Francisco, California, United States
• Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2) — San Antonio, Texas, United States
• Seattle Cancer Care Alliance Dept. of SCCA — Seattle, Washington, United States
• University of Wisconsin Univ Wisc — Madison, Wisconsin, United States
• Novartis Investigative Site — Bouge, Belgium
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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