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AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
This study is currently recruiting participants.
Verified by Amgen, April 2009
First Received: October 9, 2008   Last Updated: April 23, 2009   History of Changes
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00770848
  Purpose

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 Intervention Phase
Cancer
Castrate-Resistant Prostate Cancer
Mestastatic Prostate Cancer
Prostate Cancer
Drug: AMG 102
Phase I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Prednisone Mitoxantrone Mitoxantrone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Phase 2 - Overall survival [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
  • Phase 1b - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
  • Phase 1b - Cmax and Cmin of AMG 102 concentration [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
  • Phase 2 - Progression-free survival [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Phase 2 - Maximum percentage reduction in PSA level [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy) [ Time Frame: Treatment Period ] [ Designated as safety issue: No ]
  • Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline) [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Phase 2 - Objective response rate (CR and PR per RECIST with modifications) [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Phase 2 - Patient Report Outcome including pain-specific measures [ Time Frame: Treatment Period ] [ Designated as safety issue: No ]
  • Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]
  • Phase 2 - Incidence of anti-AMG 102 antibody formation [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
  • Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone [ Time Frame: Treatment Period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 162
Study Start Date: October 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Phase 2 - AMG 102: Experimental
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.
Phase 2 - PLACEBO: Placebo Comparator
Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770848

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, Arizona
Research Site Recruiting
Tucson, Arizona, United States
United States, California
Research Site Recruiting
San Francisco, California, United States
Research Site Recruiting
Stanford, California, United States
United States, Delaware
Research Site Recruiting
Newark, Delaware, United States
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States
United States, Missouri
Research Site Recruiting
St. Louis, Missouri, United States
United States, New York
Research Site Recruiting
Nyack, New York, United States
United States, North Carolina
Research Site Recruiting
Charlotte, North Carolina, United States
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States
United States, Washington
Research Site Recruiting
Seattle, Washington, United States
Australia
Research Site Recruiting
Parkville, Australia
Research Site Recruiting
Subiaco, Australia
Australia, South Australia
Research Site Recruiting
Adelaide, South Australia, Australia
Belgium
Research Site Recruiting
Libramont, Belgium
Research Site Recruiting
Wilrijk, Belgium
Research Site Recruiting
Brussels, Belgium
Czech Republic
Research Site Recruiting
Brno, Czech Republic
Research Site Recruiting
Pardubice, Czech Republic
Research Site Recruiting
Praha 8, Czech Republic
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20070611
Study First Received: October 9, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00770848     History of Changes
Health Authority: Euorpean Union: Ethics Committee;   United States: Food and Drug Administration;   United States: Institutional Review Board;   United States: Western Institutional Review Board

Keywords provided by Amgen:
CRPC

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Mitoxantrone
Analgesics
Peripheral Nervous System Agents
Prostatic Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Mitoxantrone
Analgesics
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009