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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01647789
First Posted: July 24, 2012
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess 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.

Condition Intervention Phase
Prostatic Neoplasms Drug: CFG920 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Incidence rate of dose limiting toxicities (DLT) [ Time Frame: 28 days (from the time of first dose) ]
    Phase l; cycle = 28 days

  • Incidence rate of patients with Prostate Specific Antigen (PSA) response [ Time Frame: >= 12 weeks ]
    Phase ll only


Secondary Outcome Measures:
  • Number of adverse events (AEs) [ Time Frame: 18 months ]
    Phase l, Phase ll

  • PK parameters [ Time Frame: 18 months ]
    Phase l, Phase ll

  • Prostate Specific Antigen (PSA) response (≥50% in PSA reduction) [ Time Frame: 18 months ]
    Phase l only

  • Progression free survival (PFS) [ Time Frame: baseline, until disease progression up to 6 months (6 cycle) ]
    Phase ll only; cycle = 28 days

  • Number of serious adverse events (SAEs) [ Time Frame: 18 months ]
    Phase l, Phase ll

  • Time to PSA progression [ Time Frame: up to 2 months (cycle 2) ]
    Phase ll; cycle = 28 days

  • Overall Response rate (ORR) [ Time Frame: up to 2 months (cycle 2) ]
    Phase ll

  • Radiological Time to Progression (rTTP) [ Time Frame: baseline, until date of documented disease progression ]
    Phase ll only

  • Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction) [ Time Frame: 18 months ]
    Phase ll only

  • Best PSA response at any time during the study [ Time Frame: 18 months ]
    Phase ll only


Other Outcome Measures:
  • Evaluation of serum hormone levels [ Time Frame: 18 months ]
    Phase I, Phase II

  • Correlate plasma exposure parameters of CFG920 and serum hormones [ Time Frame: 18 months ]
    Phase I, Phase II

  • Evaluate moleculare profiles [ Time Frame: 18 months ]
    Phase I, Phase II


Enrollment: 31
Study Start Date: December 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CFG920 Drug: CFG920

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647789


Locations
United States, California
University of California San Francisco Dept of Oncology
San Francisco, California, United States, 94101
United States, Texas
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(2)
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance Dept. of SCCA
Seattle, Washington, United States, 98109
United States, Wisconsin
University of Wisconsin Univ Wisc
Madison, Wisconsin, United States, 53792
Belgium
Novartis Investigative Site
Bouge, Belgium, 5004
Canada, Ontario
Novartis Investigative Site
Hamilton, Ontario, Canada, L8V 5C2
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01647789     History of Changes
Other Study ID Numbers: CCFG920X2101
2012-001961-33 ( EudraCT Number )
First Submitted: July 6, 2012
First Posted: July 24, 2012
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
prostate cancer, castration resistant,

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases