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| Sponsor: | Cancer International Research Group |
|---|---|
| Information provided by: | Cancer International Research Group |
| ClinicalTrials.gov Identifier: | NCT00719212 |
Purpose
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 |
|---|---|---|
|
Ovarian Neoplasms |
Biological: AMG 479 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 61 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMG 479
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.
|
Biological: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCLA | |
| Los Angeles, California, United States, 90095-1678 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | Gottfried E Konecny, MD | University of California, Los Angeles |
More Information
| Responsible Party: | Mary-Ann LINDSAY, PharmD, CIRG |
| ClinicalTrials.gov Identifier: | NCT00719212 History of Changes |
| Other Study ID Numbers: | TRIO 015 |
| Study First Received: | July 18, 2008 |
| Last Updated: | May 24, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut |
|
Neoplasms Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |