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Sponsored by: |
Cancer International Research Group |
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Information provided by: | Cancer International Research Group |
ClinicalTrials.gov Identifier: | NCT00718523 |
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
Condition | Intervention | Phase |
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Ovarian Neoplasms |
Drug: AMG 479 Drug: AMG 479 Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Multi-Center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-Like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer |
Estimated Enrollment: | 160 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2015 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
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Drug: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle.
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B: Experimental
AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
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Drug: 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:
Non diabetic patients or Type 1 or 2 Diabetic Patients:
• Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL.
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 014 |
Study First Received: | July 17, 2008 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00718523 |
Health Authority: | United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; France: Afssaps - French Health Products Safety Agency; Canada: Health Canada |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Insulin Antibodies, Monoclonal Genital Diseases, Female Antibodies Endocrinopathy Immunoglobulins Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |