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

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. Identifier: NCT01647789
Recruitment Status : Terminated
First Posted : July 24, 2012
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: CFG920 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Actual Study Start Date : December 4, 2012
Actual Primary Completion Date : February 3, 2016
Actual Study Completion Date : February 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: CFG920 Drug: CFG920

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01647789

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United States, California
UCSF Medical Center Dept of Oncology
San Francisco, California, United States, 94143
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, 98105
United States, Wisconsin
University of Wisconsin Univ Wisc
Madison, Wisconsin, United States, 53792
Novartis Investigative Site
Bouge, Belgium, 5004
Canada, Ontario
Novartis Investigative Site
Hamilton, Ontario, Canada, L8V 5C2
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01647789     History of Changes
Other Study ID Numbers: CCFG920X2101
2012-001961-33 ( EudraCT Number )
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
prostate cancer, castration resistant,
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases