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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 )
July 6, 2012
July 24, 2012
January 18, 2017
December 2012
February 2016   (Final data collection date for primary outcome measure)
  • 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
  • Incidence rate of dose limiting toxicities (DLT) [ Time Frame: 28 days (1st cycle of treatment) ]
    Phase l; cycle = 28 days
  • Patients with PSA response [ Time Frame: >= 12 weeks ]
    Phase ll only
Complete list of historical versions of study NCT01647789 on ClinicalTrials.gov Archive Site
  • 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
  • Number of adverse events (AEs) [ Time Frame: 18 months ]
    Phase l, Phase ll
  • PK parameter AUClast [ Time Frame: 18 months ]
    Phase l, Phase ll
  • Prostate Specific Antigen (PSA) response [ Time Frame: 18 months ]
    Phase l only
  • Recommended phase ll dose (RP2D) by Progression free survival (PFS) [ Time Frame: baseline, until disease progression up to 6 months (6 cycle) ]
    Phase ll only; cycle = 28 days
  • Best PSA response [ Time Frame: 18 months ]
    Phase I only
  • Change in serum hormones [ Time Frame: 18 months ]
    Phase II only
  • Number of serious adverse events (SAEs) [ Time Frame: 18 months ]
    Phase l, Phase ll
  • PK parameter Cmax [ Time Frame: up to 2 months (cycle 2) ]
    Phase l, Phase ll; cycle = 28 days
  • PK parameter Tmax [ Time Frame: up to 2 months (cycle 2) ]
    Phase l, Phase ll
  • Recommended phase ll dose (RP2D) by Radiological Progression free survival (rPFS) [ Time Frame: baseline, until disease progression up to 6 months (6 cycle) ]
    Phase ll only
  • Recommended phase ll dose (RP2D) by Proportion of patients with a decrease of ≥ 50% in the PSA concentration [ Time Frame: 18 months ]
    Phase ll only
  • Recommended phase ll dose (RP2D) by Best PSA response at any time during the study [ Time Frame: 18 months ]
    Phase ll only
  • Plasma exposure parameters of CFG920 and serum hormones [ Time Frame: 18 months ]
    Phase ll only
  • 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
Not Provided
 
A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostatic Neoplasms
Drug: CFG920
Experimental: CFG920
Intervention: Drug: CFG920
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
February 2016
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Spain,   United States
Argentina,   Brazil,   France,   Singapore
 
NCT01647789
CCFG920X2101
2012-001961-33 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP