A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/5/2018 |
| Start Date: | December 4, 2012 |
| End Date: | February 3, 2016 |
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.
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
We found this trial at
5
sites
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San Antonio, Texas 78229
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