Clincosm LogoSign in Get a demo

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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT01647789
Collaborator
(none)
31
Enrollment
7
Locations
1
Arm
38
Actual Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
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 :
Dec 4, 2012
Actual Primary Completion Date :
Feb 3, 2016
Actual Study Completion Date :
Feb 3, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: CFG920

Drug: CFG920

Outcome Measures

Primary Outcome Measures

  1. Incidence rate of dose limiting toxicities (DLT) [28 days (from the time of first dose)]

    Phase l; cycle = 28 days

  2. Incidence rate of patients with Prostate Specific Antigen (PSA) response [>= 12 weeks]

    Phase ll only

Secondary Outcome Measures

  1. Number of adverse events (AEs) [18 months]

    Phase l, Phase ll

  2. PK parameters [18 months]

    Phase l, Phase ll

  3. Prostate Specific Antigen (PSA) response (≥50% in PSA reduction) [18 months]

    Phase l only

  4. Progression free survival (PFS) [baseline, until disease progression up to 6 months (6 cycle)]

    Phase ll only; cycle = 28 days

  5. Number of serious adverse events (SAEs) [18 months]

    Phase l, Phase ll

  6. Time to PSA progression [up to 2 months (cycle 2)]

    Phase ll; cycle = 28 days

  7. Overall Response rate (ORR) [up to 2 months (cycle 2)]

    Phase ll

  8. Radiological Time to Progression (rTTP) [baseline, until date of documented disease progression]

    Phase ll only

  9. Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction) [18 months]

    Phase ll only

  10. Best PSA response at any time during the study [18 months]

    Phase ll only

Other Outcome Measures

  1. Evaluation of serum hormone levels [18 months]

    Phase I, Phase II

  2. Correlate plasma exposure parameters of CFG920 and serum hormones [18 months]

    Phase I, Phase II

  3. Evaluate moleculare profiles [18 months]

    Phase I, Phase II

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCSF Medical Center Dept of Oncology San Francisco California United States 94143
2 Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2) San Antonio Texas United States 78229
3 Seattle Cancer Care Alliance Dept. of SCCA Seattle Washington United States 98105
4 University of Wisconsin Univ Wisc Madison Wisconsin United States 53792
5 Novartis Investigative Site Bouge Belgium 5004
6 Novartis Investigative Site Hamilton Ontario Canada L8V 5C2
7 Novartis Investigative Site Barcelona Catalunya Spain 08035

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01647789
Other Study ID Numbers:
  • CCFG920X2101
  • 2012-001961-33
First Posted:
Jul 24, 2012
Last Update Posted:
Aug 3, 2018
Last Verified:
Aug 1, 2018
Keywords provided by Novartis Pharmaceuticals
prostate cancer, castration resistant,
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 3, 2018