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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00770848
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE October 9, 2008
First Posted Date  ICMJE October 10, 2008
Last Update Posted Date March 10, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Phase 1b - Incidence of adverse events defined by dose-limiting toxicities [ Time Frame: 21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP ]
  • Phase 2 - Overall survival [ Time Frame: Entire Study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
  • Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities [ Time Frame: Treatment Period ]
  • Phase 1b - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ]
  • Phase 1b - Cmax and Cmin of AMG 102 concentration [ Time Frame: Treatment Period ]
  • Phase 2 - Progression-free survival [ Time Frame: Entire Study ]
  • Phase 2 - Maximum percentage reduction in PSA level [ Time Frame: Entire Study ]
  • Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline) [ Time Frame: Entire Study ]
  • Phase 2 - Objective response rate (CR and PR per RECIST with modifications) [ Time Frame: Entire Study ]
  • Phase 2 - Patient Report Outcome including pain-specific measures [ Time Frame: Treatment Period ]
  • Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline [ Time Frame: Treatment Period ]
  • Phase 2 - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ]
  • Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone [ Time Frame: Treatment Period ]
  • Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy) [ Time Frame: Treatment Period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities [ Time Frame: Treatment Period ]
  • Phase 1b - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ]
  • Phase 1b - Cmax and Cmin of AMG 102 concentration [ Time Frame: Treatment Period ]
  • Phase 2 - Progression-free survival [ Time Frame: Entire Study ]
  • Phase 2 - Maximum percentage reduction in PSA level [ Time Frame: Entire Study ]
  • Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy) [ Time Frame: Treatment Period ]
  • Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline) [ Time Frame: Entire Study ]
  • Phase 2 - Objective response rate (CR and PR per RECIST with modifications) [ Time Frame: Entire Study ]
  • Phase 2 - Patient Report Outcome including pain-specific measures [ Time Frame: Treatment Period ]
  • Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline [ Time Frame: Treatment Period ]
  • Phase 2 - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ]
  • Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone [ Time Frame: Treatment Period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
Official Title  ICMJE 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
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 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)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Castrate-Resistant Prostate Cancer
  • Mestastatic Prostate Cancer
  • Prostate Cancer
Intervention  ICMJE
  • Drug: AMG 102
    Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
    Other Name: Rilotumumab
  • Drug: AMG 102
    Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.
    Other Name: Rilotumumab
  • Drug: Mitoxantrone
    Administered Q3W for a maximum of 12 cyles
  • Drug: Placebo
    Placebo
  • Drug: Prednisone
    5 mg orally BID
Study Arms  ICMJE
  • Phase 1b - AMG 102
    Phase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP.
    Interventions:
    • Drug: AMG 102
    • Drug: Mitoxantrone
    • Drug: Prednisone
  • Experimental: Phase 2 Arm A - AMG 102 + MP
    AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.
    Interventions:
    • Drug: AMG 102
    • Drug: Mitoxantrone
    • Drug: Prednisone
  • Placebo Comparator: Phase 2 Arm C- PLACEBO
    Placebo in combination with MP, will be administered by IV Q3W.
    Interventions:
    • Drug: Mitoxantrone
    • Drug: Placebo
    • Drug: Prednisone
  • Experimental: Phase 2 Arm B - AMG 102 + MP
    Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W
    Interventions:
    • Drug: AMG 102
    • Drug: Mitoxantrone
    • Drug: Prednisone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2008)
162
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Belgium,   Canada,   Czech Republic,   Finland,   France,   Netherlands,   Sweden,   United States
 
Administrative Information
NCT Number  ICMJE NCT00770848
Other Study ID Numbers  ICMJE 20070611
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP