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

Phase 1

Terminated

• Conditions: Prostatic Neoplasms
• Interventions: Drug: CFG920

• Registration Number: NCT01647789
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Study Start: 2012-12-04
• Primary Completion: 2016-02-03
• Study Completion: 2016-02-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CFG920	CFG920	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of dose limiting toxicities (DLT)	28 days (from the time of first dose)	Phase l; cycle = 28 days
Incidence rate of patients with Prostate Specific Antigen (PSA) response	>= 12 weeks	Phase ll only

Secondary Outcome Measures

Name	Time	Method
PK parameters	18 months	Phase l, Phase ll
Number of adverse events (AEs)	18 months	Phase l, Phase ll
Progression free survival (PFS)	baseline, until disease progression up to 6 months (6 cycle)	Phase ll only; cycle = 28 days
Number of serious adverse events (SAEs)	18 months	Phase l, Phase ll
Radiological Time to Progression (rTTP)	baseline, until date of documented disease progression	Phase ll only
Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)	18 months	Phase ll only
Best PSA response at any time during the study	18 months	Phase ll only
Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)	18 months	Phase l only
Time to PSA progression	up to 2 months (cycle 2)	Phase ll; cycle = 28 days
Overall Response rate (ORR)	up to 2 months (cycle 2)	Phase ll

Trial Locations

Locations (5)

UCSF Medical Center Dept of Oncology; 🇺🇸 San Francisco, California, United States

Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2); 🇺🇸 San Antonio, Texas, United States

Seattle Cancer Care Alliance Dept. of SCCA; 🇺🇸 Seattle, Washington, United States

University of Wisconsin Univ Wisc; 🇺🇸 Madison, Wisconsin, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Catalunya, Spain