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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001961-33 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CFG920 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CFG920 | Drug |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | Phase l, Phase ll | 18 months |
| PK parameters | Phase l, Phase ll | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of serum hormone levels | Phase I, Phase II | 18 months |
| Correlate plasma exposure parameters of CFG920 and serum hormones | Phase I, Phase II |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center Dept of Oncology | San Francisco | California | 94143 | United States | ||
| Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| 18 months |
| Evaluate moleculare profiles | Phase I, Phase II | 18 months |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Seattle Cancer Care Alliance Dept. of SCCA | Seattle | Washington | 98105 | United States |
| University of Wisconsin Univ Wisc | Madison | Wisconsin | 53792 | United States |
| Novartis Investigative Site | Bouge | 5004 | Belgium |
| Novartis Investigative Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |