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Sponsors and Collaborators: |
PDL BioPharma, Inc. Biogen Idec |
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Information provided by: | PDL BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00516841 |
To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Neoplasms |
Drug: Volociximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 56 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Screening clinical laboratory values:
Principal Investigator: | Carolyn Matthews, MD | Mary Crowley Medical Research Center |
Principal Investigator: | Minal Barve, MD | Texas Oncology PA, Presbyterian |
Principal Investigator: | James Burke, MD | Billings Clinic (MCMRC network) |
Principal Investigator: | Dana Glenn, MD | Sharp Hospital |
Principal Investigator: | Russell Schilder, MD | Fox Chase Cancer Center |
Principal Investigator: | Nikki Spellman, MD | Indiana University |
Principal Investigator: | Michael Gold, MD | Oklahoma University Health Science Center |
Principal Investigator: | Richard Penson, MD | Massachusetts General Hospital |
Principal Investigator: | Mark Einstein, MD | Montefiore Medical Center |
Principal Investigator: | Robert Holloway, MD | Florida Hospital Cancer Institute |
Principal Investigator: | Deborah Armstrong, MD | Johns Hopkins Kimmel Cancer Center |
Principal Investigator: | Snehel Bhoola, MD | Memorial Health University Medical Center |
Principal Investigator: | Eric Winquist, MD | London Health Sciences Center |
Principal Investigator: | Ernst Lengyel, MD | University of Chicago |
Principal Investigator: | John Glaspy, MD | UCLA JCCC Clinical Research Unit |
Principal Investigator: | Krish Tewari, MD | UCI Medical Center |
Principal Investigator: | C. William Helm, MD | James Graham Brown Cancer Center |
Principal Investigator: | John Glaspy, MD | University of California, Los Angeles |
Principal Investigator: | Michael Sawyer, MD | Cross Cancer Institute |
Responsible Party: | PDL BioPharma, Inc. ( Jill Henrich ) |
Study ID Numbers: | 206OC201 |
Study First Received: | August 14, 2007 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00516841 |
Health Authority: | United States: Food and Drug Administration |
epithelial ovarian cancer peritoneal cancer platinum-resistant ovarian cancer Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Abdominal Neoplasms Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |