Clinical trial NCT01647789: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Prostatic Neoplasms
Keywords: prostate cancer, castration resistant,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence rate of dose limiting toxicities (DLT)
timeFrame: 28 days (from the time of first dose)
measure: Incidence rate of patients with Prostate Specific Antigen (PSA) response
timeFrame: >= 12 weeks
Secondary outcomes:
measure: Number of adverse events (AEs)
timeFrame: 18 months
measure: PK parameters
timeFrame: 18 months
measure: Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)
timeFrame: 18 months
measure: Progression free survival (PFS)
timeFrame: baseline, until disease progression up to 6 months (6 cycle)
measure: Number of serious adverse events (SAEs)
timeFrame: 18 months
measure: Time to PSA progression
timeFrame: up to 2 months (cycle 2)
measure: Overall Response rate (ORR)
timeFrame: up to 2 months (cycle 2)
measure: Radiological Time to Progression (rTTP)
timeFrame: baseline, until date of documented disease progression
measure: Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)
timeFrame: 18 months
measure: Best PSA response at any time during the study
timeFrame: 18 months
Other outcomes:
measure: Evaluation of serum hormone levels
timeFrame: 18 months
measure: Correlate plasma exposure parameters of CFG920 and serum hormones
timeFrame: 18 months
measure: Evaluate moleculare profiles
timeFrame: 18 months
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center Dept of Oncology
state: California
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2)
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance Dept. of SCCA
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Univ Wisc
state: Wisconsin
city: Bouge
country: Belgium
facility: Novartis Investigative Site
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: