Status:
COMPLETED
AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
Lead Sponsor:
Amgen
Conditions:
Cancer
Castrate-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate w...
Eligibility Criteria
Inclusion
- Pathologically confirmed adenocarcinoma of the prostate
- Radiographic evidence of metastatic disease
- Progressive disease meeting at least one of the following criteria:
- 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
- progression according to RECIST criteria for measurable lesions, or
- 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
Exclusion
- 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 major surgery
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00770848
Start Date
November 1 2008
End Date
April 1 2012
Last Update
March 10 2014
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