Prostatic Neoplasms
Conditions
Keywords
prostate cancer, castration resistant,
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.
Interventions
DRUGCFG920
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of patients with Prostate Specific Antigen (PSA) response | >= 12 weeks | Phase ll only |
| Incidence rate of dose limiting toxicities (DLT) | 28 days (from the time of first dose) | Phase l; cycle = 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters | 18 months | Phase l, Phase ll |
| Prostate Specific Antigen (PSA) response (≥50% in PSA reduction) | 18 months | Phase l only |
| 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 |
| Number of adverse events (AEs) | 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlate plasma exposure parameters of CFG920 and serum hormones | 18 months | Phase I, Phase II |
| Evaluate moleculare profiles | 18 months | Phase I, Phase II |
| Evaluation of serum hormone levels | 18 months | Phase I, Phase II |
Countries
Belgium, Canada, Spain, United States
Outcome results
None listed