Back to resultsA Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CFG920
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate cancer, castration resistant,
Eligibility Criteria
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
Sites / Locations
- UCSF Medical Center Dept of Oncology
- Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2)
- Seattle Cancer Care Alliance Dept. of SCCA
- University of Wisconsin Univ Wisc
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CFG920
Arm Description
Outcomes
Primary Outcome Measures
Incidence rate of dose limiting toxicities (DLT)
Phase l; cycle = 28 days
Incidence rate of patients with Prostate Specific Antigen (PSA) response
Phase ll only
Secondary Outcome Measures
Number of adverse events (AEs)
Phase l, Phase ll
PK parameters
Phase l, Phase ll
Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)
Phase l only
Progression free survival (PFS)
Phase ll only; cycle = 28 days
Number of serious adverse events (SAEs)
Phase l, Phase ll
Time to PSA progression
Phase ll; cycle = 28 days
Overall Response rate (ORR)
Phase ll
Radiological Time to Progression (rTTP)
Phase ll only
Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)
Phase ll only
Best PSA response at any time during the study
Phase ll only
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01647789
Brief Title
A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
Official Title
A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
December 4, 2012 (Actual)
Primary Completion Date
February 3, 2016 (Actual)
Study Completion Date
February 3, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
prostate cancer, castration resistant,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CFG920
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CFG920
Primary Outcome Measure Information:
Title
Incidence rate of dose limiting toxicities (DLT)
Description
Phase l; cycle = 28 days
Time Frame
28 days (from the time of first dose)
Title
Incidence rate of patients with Prostate Specific Antigen (PSA) response
Description
Phase ll only
Time Frame
>= 12 weeks
Secondary Outcome Measure Information:
Title
Number of adverse events (AEs)
Description
Phase l, Phase ll
Time Frame
18 months
Title
PK parameters
Description
Phase l, Phase ll
Time Frame
18 months
Title
Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)
Description
Phase l only
Time Frame
18 months
Title
Progression free survival (PFS)
Description
Phase ll only; cycle = 28 days
Time Frame
baseline, until disease progression up to 6 months (6 cycle)
Title
Number of serious adverse events (SAEs)
Description
Phase l, Phase ll
Time Frame
18 months
Title
Time to PSA progression
Description
Phase ll; cycle = 28 days
Time Frame
up to 2 months (cycle 2)
Title
Overall Response rate (ORR)
Description
Phase ll
Time Frame
up to 2 months (cycle 2)
Title
Radiological Time to Progression (rTTP)
Description
Phase ll only
Time Frame
baseline, until date of documented disease progression
Title
Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)
Description
Phase ll only
Time Frame
18 months
Title
Best PSA response at any time during the study
Description
Phase ll only
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Evaluation of serum hormone levels
Description
Phase I, Phase II
Time Frame
18 months
Title
Correlate plasma exposure parameters of CFG920 and serum hormones
Description
Phase I, Phase II
Time Frame
18 months
Title
Evaluate moleculare profiles
Description
Phase I, Phase II
Time Frame
18 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Medical Center Dept of Oncology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seattle Cancer Care Alliance Dept. of SCCA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Wisconsin Univ Wisc
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Novartis Investigative Site
City
Bouge
ZIP/Postal Code
5004
Country
Belgium
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
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A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
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