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

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01647789
First received: July 6, 2012
Last updated: January 24, 2014
Last verified: January 2014

July 6, 2012
January 24, 2014
December 2012
January 2015   (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) ] [ 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
  • Incidence rate of dose limiting toxicities (DLT) [ Time Frame: 28 days (1st cycle of treatment) ] [ Designated as safety issue: Yes ]
    Phase l; cycle = 28 days
  • Patients with PSA response [ Time Frame: >= 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ 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
  • Number of adverse events (AEs) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Phase l, Phase ll
  • PK parameter AUClast [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase l, Phase ll
  • Prostate specific antigen (PSA) response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Phase ll only; cycle = 28 days
  • Best PSA response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase I only
  • Change in serum hormones [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase II only
  • Number of serious adverse events (SAEs) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Phase l, Phase ll
  • PK parameter Cmax [ Time Frame: up to 2 months (cycle 2) ] [ Designated as safety issue: No ]
    Phase l, Phase ll; cycle = 28 days
  • PK parameter Tmax [ Time Frame: up to 2 months (cycle 2) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Phase ll only
  • Recommended phase ll dose (RP2D) by Best PSA response at any time during the study [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase ll only
  • Plasma exposure parameters of CFG920 and serum hormones [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Phase ll only
  • 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
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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
75
January 2015
January 2015   (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
Male
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Argentina,   Belgium,   Brazil,   Canada,   France,   Singapore,   Spain
 
NCT01647789
CCFG920X2101, 2012-001961-33
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

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