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Brief Title: Study of Ramucirumab in Ovarian Cancer
Official Title: A Phase 2, Non-randomized, Open-label, Multicenter Study of IMC-1121B in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study ID: NCT00721162
Brief Summary: The purpose of this study is to determine if ramucirumab given as monotherapy is effective in the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.
Detailed Description: Current chemotherapies used to treat ovarian cancer participants include doxorubicin, topotecan, and paclitaxel, to mention a few. Doxorubicin was studied in ovarian cancer participants that were refractory to paclitaxel and platinum-based chemotherapy agents. Inhibition of angiogenesis is considered a promising approach to the treatment of cancer. Vascular endothelial growth factor (VEGF) is an important regulator of angiogenesis and is likely an important therapeutic target in persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. VEGF is overexpressed in ovarian tissue and may be the most important single tumor angiogenic factor. Phase 1 studies currently nearing completion with ramucirumab have demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence of clinical efficacy in ovarian cancer participants. Therefore, ImClone Systems plans to conduct a Phase 2 trial to assess the safety and efficacy of ramucirumab in participants with platinum-refractory persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
ImClone Investigational Site, Hollywood, Florida, United States
ImClone Investigational Site, Orlando, Florida, United States
ImClone Investigational Site, Chicago, Illinois, United States
ImClone Investigational Site, Marrero, Louisiana, United States
ImClone Investigational Site, Metairie, Louisiana, United States
ImClone Investigational Site, Baltimore, Maryland, United States
ImClone Investigational Site, Boston, Massachusetts, United States
ImClone Investigational Site, Rochester, Minnesota, United States
ImClone Investigational Site, Oklahoma City, Oklahoma, United States
ImClone Investigational Site, Houston, Texas, United States
ImClone Investigational Site, Seattle, Washington, United States
ImClone Investigational Site, London, , United Kingdom
ImClone Investigational Site, Sutton, , United Kingdom
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR