NCT01647789

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2012

Typical duration for phase_1

Geographic Reach
4 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

December 4, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2016

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

July 6, 2012

Last Update Submit

August 1, 2018

Conditions

Prostatic Neoplasms

Keywords

prostate cancer, castration resistant,

Outcome Measures

Primary Outcomes (2)

  • Incidence rate of dose limiting toxicities (DLT)

    Phase l; cycle = 28 days

    28 days (from the time of first dose)

  • Incidence rate of patients with Prostate Specific Antigen (PSA) response

    Phase ll only

    >= 12 weeks

Secondary Outcomes (10)

  • Number of adverse events (AEs)

    18 months

  • PK parameters

    18 months

  • Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)

    18 months

  • Progression free survival (PFS)

    baseline, until disease progression up to 6 months (6 cycle)

  • Number of serious adverse events (SAEs)

    18 months

  • +5 more secondary outcomes

Other Outcomes (3)

  • Evaluation of serum hormone levels

    18 months

  • Correlate plasma exposure parameters of CFG920 and serum hormones

    18 months

  • Evaluate moleculare profiles

    18 months

Study Arms (1)

CFG920

EXPERIMENTAL
Drug: CFG920

Interventions

CFG920DRUG
CFG920

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCSF Medical Center Dept of Oncology

San Francisco, California, 94143, United States

Location

Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2)

San Antonio, Texas, 78229, United States

Location

Seattle Cancer Care Alliance Dept. of SCCA

Seattle, Washington, 98105, United States

Location

University of Wisconsin Univ Wisc

Madison, Wisconsin, 53792, United States

Location

Novartis Investigative Site

Bouge, 5004, Belgium

Location

Novartis Investigative Site

Hamilton, Ontario, L8V 5C2, Canada

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 24, 2012

Study Start

December 4, 2012

Primary Completion

February 3, 2016

Study Completion

February 3, 2016

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

BE(1)CA(1)US(4)ES(1)