Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00313781 | Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC) | PHASE2 | COMPLETED | 204 | — | — | May 1, 2006 | Dec 1, 2011 | Apr 11, 2013 | 18 | United States, Canada +4 |
Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =\< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as \>= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance. |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CP-751,871 | DRUG | CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days). |
| docetaxel | DRUG | Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. |
| prednisone | DRUG | Prednisone is administered at a dose of 5 mg twice daily. |
Inclusion Criteria: * Diagnosis of metastatic, progressive hormone refractory prostate cancer * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Previous treatment with chemotherapy