An interventional study of oral CFG920 in patients with castration resistant prostate cancer
- Conditions
- Metastatic prostate cancerMedDRA version: 17.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001961-33-BE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 75
-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
- Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
- 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 exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase I:To estimate the Maximum Tolerated Dose (MTD) or recommended phase II dose (RP2D) of oral CFG920 when co-administered with prednisone to adult patients with castration-resistant prostate cancer. <br>Phase II: To assess preliminary anti-tumor activity of CFG920 across 3 castration-resistant prostate cancer groups:1) Abiraterone- naïve, 2) Abiraterone primary resistant, 3) Abiraterone secondary resistant;Secondary Objective: 1. Phase I and II: To characterize the safety and tolerability of CFG920,<br>including both acute and chronic toxicities<br>2. Phase I and II: To characterize the PK of CFG920<br>3. Phase I : Evaluate preliminary antitumor activity<br>4. Phase II: Evaluate preliminary antitumor activity;Primary end point(s): Phase I: Incidence rate of dose limiting toxicities (DLT)<br>Phase II:Rate of patients with PSA response;Timepoint(s) of evaluation of this end point: Phase I: 1st cycle of treatment<br>Phase II:baseline, >= 12 weeks
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1. 18 months<br>2.18 months<br>3. 18 months<br>4. a) baseline, until disease progression up to 6 months (6 cycle), b) and<br>c) up to 2 months (cycle 2), d) baseline, until date of documented<br>disease progression e) and f) 18 months;Secondary end point(s): 1. Number of adverse events (AEs), Number of serious adverse events<br>(SAEs)<br>2. PK parameter<br>3. Prostate specific antigen (PSA) response (=50% in PSA reduction),<br>4. a) Progression free survival (PFS), b)Time to PSA progression,<br>c)Overall Response rate (ORR), d)Radiological Time to Progression<br>(rTTP), e)Prostate Specific Antigen (PSA) response (=30% in the PSA<br>reduction, f)Best PSA response at any time during the study