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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
Open (Enrolling)
Male
Prostatic Neoplasms

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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 WiscMadison, Wisconsin  53792
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept. of SCCASeattle, Washington  98109-1023
University of California San Francisco Dept of OncologySan Francisco, California  94101
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(2)San Antonio, Texas  78229