A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence rate of dose limiting toxicities (DLT)
Outcome Description:
Phase l; cycle = 28 days
Outcome Time Frame:
28 days (from the time of first dose)
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CCFG920X2101
NCT ID:
NCT01647789
Start Date:
January 2012
Completion Date:
January 2015
Related Keywords:
- Prostatic Neoplasms
- prostate cancer, castration resistant,
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Wisconsin Univ Wisc | Madison, Wisconsin 53792 |
| Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept. of SCCA | Seattle, Washington 98109-1023 |
| University of California San Francisco Dept of Oncology | San Francisco, California 94101 |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(2) | San Antonio, Texas 78229 |
