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

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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

Study Description
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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)


Condition or disease Intervention/treatment Phase
Cancer Castrate-Resistant Prostate Cancer Mestastatic Prostate Cancer Prostate Cancer Drug: AMG 102 Drug: Mitoxantrone Drug: Placebo Drug: Prednisone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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: Prednisone
5 mg orally BID
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.
 Drug: AMG 102
Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
Other Name: Rilotumumab

Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles

Drug: Prednisone
5 mg orally BID
Placebo Comparator: Phase 2 Arm C- PLACEBO
Placebo in combination with MP, will be administered by IV Q3W.
 Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles

Drug: Placebo
Placebo

Drug: Prednisone
5 mg orally BID
Experimental: Phase 2 Arm B - AMG 102 + MP
Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W
 Drug: AMG 102
Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
Other Name: Rilotumumab

Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles

Drug: Prednisone
5 mg orally BID


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Phase 2 - Overall survival [ Time Frame: Entire Study ]

Secondary Outcome Measures :
  1. Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities [ Time Frame: Treatment Period ]
  2. Phase 1b - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ]
  3. Phase 1b - Cmax and Cmin of AMG 102 concentration [ Time Frame: Treatment Period ]
  4. Phase 2 - Progression-free survival [ Time Frame: Entire Study ]
  5. Phase 2 - Maximum percentage reduction in PSA level [ Time Frame: Entire Study ]
  6. Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline) [ Time Frame: Entire Study ]
  7. Phase 2 - Objective response rate (CR and PR per RECIST with modifications) [ Time Frame: Entire Study ]
  8. Phase 2 - Patient Report Outcome including pain-specific measures [ Time Frame: Treatment Period ]
  9. Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline [ Time Frame: Treatment Period ]
  10. Phase 2 - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ]
  11. Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone [ Time Frame: Treatment Period ]
  12. Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy) [ Time Frame: Treatment Period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770848


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:
Oliner K.BM Ph2 CRPC.Journal-004521;

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00770848    
Other Study ID Numbers: 20070611
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: February 2014
Keywords provided by Amgen:
CRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Mitoxantrone
Rilotumumab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors