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Sponsored by: |
Cancer International Research Group |
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Information provided by: | Cancer International Research Group |
ClinicalTrials.gov Identifier: | NCT00719212 |
The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.
Condition | Intervention | Phase |
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Ovarian Neoplasms |
Biological: AMG 479 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Open Label Phase II Study of the Efficacy and Safety of AMG 479, a Fully Human Monoclonal Antibody Against Insulin-Like Growth Factor Type 1 Receptor (IGF-1R) as Second Line Therapy in Patients With Recurrent Platinum Sensitive Ovarian Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 479: Experimental
AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.
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Biological: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Henry Taupin | + 33 1 58 10 08 85 | henry.taupin@cirg.org |
United States, California | |
UCLA | |
Los Angeles, California, United States, 90095-1678 |
Study Chair: | Gottfried E Konecny, MD | University of California, Los Angeles |
Responsible Party: | CIRG ( Mary-Ann LINDSAY, PharmD ) |
Study ID Numbers: | TRIO 015 |
Study First Received: | July 18, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00719212 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Recurrence |
Insulin Antibodies, Monoclonal Genital Diseases, Female Antibodies Endocrinopathy Immunoglobulins Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |