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| Sponsor: | Cancer International Research Group |
|---|---|
| Information provided by (Responsible Party): | Cancer International Research Group |
| ClinicalTrials.gov Identifier: | NCT00718523 |
Purpose
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 |
|---|---|---|
|
Ovarian Neoplasms |
Drug: AMG 479 Drug: AMG 479 Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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: | January 2009 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
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.
|
Drug: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle.
|
|
Experimental: B
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.
|
Drug: 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:
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:
Contacts and Locations| Contact: Matthieu Rupin | + 33 1 58 10 08 89 | matthieu.rupin@trioncology.org |
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1678 | |
| Sub-Investigator: Gottfried E Koneckny, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Paul Haluska | |
| Principal Investigator: Paul Haluska | |
| Study Chair: | Gottfried E Konecny, MD | University of California, Los Angeles |
More Information
| Responsible Party: | Cancer International Research Group |
| ClinicalTrials.gov Identifier: | NCT00718523 History of Changes |
| Other Study ID Numbers: | TRIO 014 |
| Study First Received: | July 17, 2008 |
| Last Updated: | December 1, 2011 |
| Health Authority: | United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; France: Afssaps - French Health Products Safety Agency; Canada: Health Canada |
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Neoplasms Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |