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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01647789
First received: July 6, 2012
Last updated: April 24, 2014
Last verified: April 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

  • Incidence rate of patients with Prostate Specific Antigen (PSA) response [ Time Frame: >= 12 weeks ] [ Designated as safety issue: No ]
    Phase ll only


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

  • PK parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase l, Phase ll

  • Prostate Specific Antigen (PSA) response (≥50% in PSA reduction) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase l only

  • Progression free survival (PFS) [ Time Frame: baseline, until disease progression up to 6 months (6 cycle) ] [ Designated as safety issue: No ]
    Phase ll only; cycle = 28 days

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

  • Time to PSA progression [ Time Frame: up to 2 months (cycle 2) ] [ Designated as safety issue: No ]
    Phase ll; cycle = 28 days

  • Overall Response rate (ORR) [ Time Frame: up to 2 months (cycle 2) ] [ Designated as safety issue: No ]
    Phase ll

  • Radiological Time to Progression (rTTP) [ Time Frame: baseline, until date of documented disease progression ] [ Designated as safety issue: No ]
    Phase ll only

  • Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase ll only

  • Best PSA response at any time during the study [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase ll only


Other Outcome Measures:
  • Evaluation of serum hormone levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase I, Phase II

  • Correlate plasma exposure parameters of CFG920 and serum hormones [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase I, Phase II

  • Evaluate moleculare profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase I, Phase II


Estimated Enrollment: 75
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CFG920 Drug: CFG920

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647789

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
University of California San Francisco Dept of Oncology Active, not recruiting
San Francisco, California, United States, 94101
United States, Massachusetts
Massachusetts General Hospital Mass General Withdrawn
Boston, Massachusetts, United States, 02114
United States, Texas
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(2) Completed
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept. of SCCA Active, not recruiting
Seattle, Washington, United States, 98109-1023
United States, Wisconsin
University of Wisconsin Univ Wisc Completed
Madison, Wisconsin, United States, 53792
Argentina
Novartis Investigative Site Not yet recruiting
Caba, Buenos Aires, Argentina, C1431FWO
Novartis Investigative Site Not yet recruiting
Buenos Aires, Argentina, C1050AAK
Belgium
Novartis Investigative Site Recruiting
Bouge, Belgium, 5004
Brazil
Novartis Investigative Site Not yet recruiting
Rio de Janiero, RJ, Brazil, 20231-050
Novartis Investigative Site Not yet recruiting
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site Not yet recruiting
Barretos, SP, Brazil, 14784-400
Novartis Investigative Site Not yet recruiting
São Paulo, SP, Brazil, 01246-000
Canada, Ontario
Novartis Investigative Site Recruiting
Hamilton, Ontario, Canada, L8V 5C2
France
Novartis Investigative Site Not yet recruiting
Lyon Cedex, France, 69373
Singapore
Novartis Investigative Site Not yet recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01647789     History of Changes
Other Study ID Numbers: CCFG920X2101, 2012-001961-33
Study First Received: July 6, 2012
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
prostate cancer, castration resistant,

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

ClinicalTrials.gov processed this record on July 28, 2014