A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
- 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
- For patients without a history of surgical castration, continued GnRH analog
administration is required
- ECOG Performance status of 0 or 1
- Life expectancy ≥ 3 months
- 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.
- Known CNS metastases (epidural disease is allowed if it has been treated and there is
no progression in the treated area).
- Significant cardiovascular disease
- LVEF < 50% by MUGA or ECHO
- 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
- Presence of peripheral edema > Grade 2
- Known positive test for HIV, hepatitis C, chronic or active hepatitis B
- Serious or non-healing wound
- Unable to begin protocol specified treatment within 7 days after enrollment
- Other investigational procedures are excluded.