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Study Complete
Sponsor ID
20070611

AMG 102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

Sponsor ID
20070611
Clinicaltrials.gov ID
NCT00770848
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 102
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
162
Additional Study Details

Protocol Summary

Primary Outcome Measures

Phase 1b - Incidence of adverse events defined by dose-limiting toxicities

Timeframe: 21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP

Phase 2 - Overall survival

Timeframe: Entire Study

Secondary Outcome Measures

Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities

Timeframe: Treatment Period

Phase 1b - Incidence of anti-AMG 102 antibody formation

Timeframe: Entire Study

Phase 1b - Cmax and Cmin of AMG 102 concentration

Timeframe: Treatment Period

Phase 2 - Progression-free survival

Timeframe: Entire Study

Phase 2 - Maximum percentage reduction in PSA level

Timeframe: Entire Study

Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline)

Timeframe: Entire Study

Phase 2 - Objective response rate (CR and PR per RECIST with modifications)

Timeframe: Entire Study

Phase 2 - Patient Report Outcome including pain-specific measures

Timeframe: Treatment Period

Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline

Timeframe: Treatment Period

Phase 2 - Incidence of anti-AMG 102 antibody formation

Timeframe: Entire Study

Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone

Timeframe: Treatment Period

Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy)

Timeframe: Treatment Period

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Cancer - Other
    • Show more
  • Prostate Cancer
    • Sex
    Assigned Male at Birth
    Trial Dates
    Nov 2008 - Jan 2011
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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
    Exclusion Criteria:
    - 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.