A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination withMitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

Amgen Inc0 sites162 target enrollmentMay 21, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 21, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•Disease\-related
•Pathologically confirmed adenocarcinoma of the prostate
•Radiographic evidence of metastatic disease
•Progressive disease meeting at least one of the following criteria:
•1\) a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or
•2\) progression according to RECIST criteria for measurable lesions, or
•3\) appearance of 2 or more new lesions on bone scan.
•History of prior taxane\-based chemotherapy for metastatic prostate cancer; no more than one prior chemotherapy regimen for CRPC is allowed (estramustine will be considered as chemotherapy)
•ECOG Performance status 0 or 1
•Life expectancy \= 3 months

•Disease\-related
•Treatment with external beam radiotherapy \= 14 days before enrollment or radiopharmaceutical \=8 weeks
•\= 4 weeks since receipt of most recent prior chemotherapy, non\-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and \<6 weeks since receipt of prior bevacizumab. Patients with evidence of an antiandrogen withdrawal response must demonstrate objective or PSA progression following the response.
•Known CNS metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
•Significant cardiovascular disease (CHF class III or IV, uncontrolled angina, MI within 6 months of enrollment); patients with medically stable atrial fibrillation may be included.
•LVEF \< 50% by MUGA or ECHO
•Medications
•Treatment of infection with systemic anti\-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
•Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin\-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed
•Major surgical procedure \= 30 days before enrollment or not yet recovered from prior major surgery