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
- Conditions
- Prostate Cancer1003859410036958
- Registration Number
- NL-OMON33942
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* 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
* Men * 18 years of age
* 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.
* Subjects 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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase 2;<br /><br>To estimate with adequate precision the effect of the addition of AMG 102 to<br /><br>MP, compared with placebo + MP, as assessed by the hazard ratio (HR) for<br /><br>overall survival (OS) of previously treated subjects with castrate resistant<br /><br>prostate cancer (CRPC).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Phase 2;<br /><br>- Progression free survival (PFS), objective response rate (ORR) as measured by<br /><br>modified RECIST, percentage changes in prostate specific antigen (PSA) level<br /><br>and response rates.<br /><br>- Patient reported outcomes, including pain.<br /><br>- The incidence of adverse events, laboratory abnormalities.<br /><br>- The incidence of anti-AMG 102 antibody formation.<br /><br>- Pharmacokinetics (PK): Cmax and Cmin for AMG 102</p><br>