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

Prostatic Neoplasms Clinical Trial

Official title:

A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01647789
• Other study ID #: CCFG920X2101
• Secondary ID: 2012-001961-33
• Status: Terminated
• Phase: Phase 1
• Start date: December 4, 2012
• Est. completion date: February 3, 2016

Study information

• Verified date: August 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 3, 2016
• Est. primary completion date: February 3, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• CFG920

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Bouge
Canada	Novartis Investigative Site	Hamilton	Ontario
Spain	Novartis Investigative Site	Barcelona	Catalunya
United States	University of Wisconsin Univ Wisc	Madison	Wisconsin
United States	Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2)	San Antonio	Texas
United States	UCSF Medical Center Dept of Oncology	San Francisco	California
United States	Seattle Cancer Care Alliance Dept. of SCCA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of serum hormone levels	Phase I, Phase II	18 months
Other	Correlate plasma exposure parameters of CFG920 and serum hormones	Phase I, Phase II	18 months
Other	Evaluate moleculare profiles	Phase I, Phase II	18 months
Primary	Incidence rate of dose limiting toxicities (DLT)	Phase l; cycle = 28 days	28 days (from the time of first dose)
Primary	Incidence rate of patients with Prostate Specific Antigen (PSA) response	Phase ll only	>= 12 weeks
Secondary	Number of adverse events (AEs)	Phase l, Phase ll	18 months
Secondary	?PK parameters	Phase l, Phase ll	18 months
Secondary	Prostate Specific Antigen (PSA) response (=50% in PSA reduction)	Phase l only	18 months
Secondary	Progression free survival (PFS)	Phase ll only; cycle = 28 days	baseline, until disease progression up to 6 months (6 cycle)
Secondary	Number of serious adverse events (SAEs)	Phase l, Phase ll	18 months
Secondary	Time to PSA progression	Phase ll; cycle = 28 days	up to 2 months (cycle 2)
Secondary	Overall Response rate (ORR)	Phase ll	up to 2 months (cycle 2)
Secondary	Radiological Time to Progression (rTTP)	Phase ll only	baseline, until date of documented disease progression
Secondary	Prostate Specific Antigen (PSA) response (=30% in the PSA reduction)	Phase ll only	18 months
Secondary	Best PSA response at any time during the study	Phase ll only	18 months

External Links

•   Link to Novartisclinicaltrials.com