Phase 2
N=204
Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
Prostatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00313781 ↗Enrolled (actual)
204
Serious AEs
51.3%
Results posted
Apr 2013
Primary outcome: Primary: Percentage of Participants With Prostate Specific Antigen (PSA) Best Response — 51.7; 60.2; 28.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CP-751,871 (Drug); docetaxel (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Prostate Specific Antigen (PSA) Best Response |
51.7; 60.2; 28.1 | — |
| SECONDARY Progression Free Survival (PFS) |
4.9; 7.7; 4.0 | — |
| SECONDARY Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1) |
1130.3; 1338.1 | — |
| SECONDARY Human Anti-human Antibody (HAHA) at the Last Follow-up Visit |
944.81; 819.00; 970.86 | — |
| SECONDARY Population PK Parameters of CP-751,871 |
— | — |
| SECONDARY Total Number of Circulation Tumor Cells (CTCs) |
105.17; 213.23; 6.39; 12.21; 15.20; 17.78 | — |
| SECONDARY Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs |
24.73; 54.94; 2.33; 4.93; 2.00; 3.90 | — |
| SECONDARY Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P) |
— | — |
| SECONDARY Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer) |
— | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871 |
— | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for CP-751,871 |
— | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871 |
— | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871 |
— | — |
Summary
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy
Eligibility Criteria
Inclusion Criteria
- Diagnosis of metastatic, progressive hormone refractory prostate cancer
- Adequate bone marrow, liver and kidney function
Exclusion Criteria
- Previous treatment with chemotherapy
Data sourced from ClinicalTrials.gov (NCT00313781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.