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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: CFG920


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CFG920<br> | Drug: CFG920<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, castration resistant,