Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00770848 |
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 |
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 |
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Progressive disease meeting at least one of the following criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
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 |
Study Director: | MD | Amgen |
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 |
CRPC |
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 |
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 |