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Figitumumab + Docetaxel/Prednisone in Prostate Cancer

NCT00313781Phase 2

Key facts

Status: Completed
Start: May 2006
Primary completion: Apr 2011
Countries: 6
Sponsor: Pfizer
Modality: Monoclonal Antibodies

Drugs: figitumumab
Conditions: prostate cancer (PCa)

Overview

Phase 2, randomised, open-label trial of figitumumab in prostate cancer (PCa) (2 arms), sponsored by Pfizer. Primary endpoint: Percentage of Participants With Prostate Specific Antigen (PSA) Best Response. Started May 2006; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Chemotherapy-Naive
Docetaxel + Prednisone, then add Figitumumab on progression
Refractory
Docetaxel + Prednisone + Figitumumab

Who it enrols

Patients with metastatic, progressive hormone refractory prostate cancer. Arm A excludes previous chemotherapy, while Arm B requires prior Docetaxel/Prednisone treatment (refractory).

Endpoints

Primary

Percentage of Participants With Prostate Specific Antigen (PSA) Best ResponseFollow-up (up to 150 days)

Secondary

Progression Free SurvivalFollow-up (up to 150 days)
Human Anti-human AntibodyLast Follow-up Visit
Population PK Parameters of CP-751,871Last follow-up visit
Total Number of Circulation Tumor CellsEnd of treatment
Total Number of the Insulin Like Growth Factor Receptor Type 1 Positive CTCsEnd of treatment
Quality of Life Measured by the Functional Assessment of Cancer Treatment-ProstateEnd of treatment
Pain Measured by the Modified Brief Pain Inventory-Short FormEnd of treatment
Area Under the Curve From Time Zero to Last Quantifiable Concentration for CP-751,871Last follow-up visit

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