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Sponsored by: |
Calando Pharmaceuticals |
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Information provided by: | Calando Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00753740 |
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
Condition | Intervention | Phase |
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Cancer Ovarian Cancer Solid Tumor |
Drug: IT-101 (12mg/m2/dose) Drug: IT-101 (15mg/m2/dose) Drug: 5% Dextrose (Placebo) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression. |
Estimated Enrollment: | 150 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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12mg/m2/dose: Experimental
12mg per meter squared per dose
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Drug: IT-101 (12mg/m2/dose)
Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.
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15mg/m2/dose: Experimental
15mg per meter squared per dose
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Drug: IT-101 (15mg/m2/dose)
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.
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Placebo: Placebo Comparator
5% dextrose infusion (placebo)
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Drug: 5% Dextrose (Placebo)
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.
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Ages Eligible for Study: | 18 Years to 78 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
United States, Illinois | |
Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of Illinois | |
Decatur, Illinois, United States, 62526 | |
United States, Minnesota | |
University of Minnesota Medical Center | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Schwartz Gynecologic Onclology, PLLC | |
Brightwaters, New York, United States, 11718 | |
United States, Ohio | |
Gabrail Cancer Center | |
Canton, Ohio, United States, 44718 | |
United States, Tennessee | |
Chattanooga GYN Oncology | |
Chattanooga, Tennessee, United States, 97403 | |
United States, Texas | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Riverside Gynecology & Oncology | |
Newport News, Virginia, United States, 23601 |
Principal Investigator: | Jonathan S Berek, MD, MMS | Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center |
Principal Investigator: | Franco Muggia, MD | Anne Murnick Cogan and David H. Cogan Professor of Oncology, Director of the Division of Medical Oncology at NYU Medical Center, and Associate Director for Clinical Research |
Responsible Party: | For Calando Pharmaceuticals ( James Oliver, Pharm. D. ) |
Study ID Numbers: | OVAR0801 |
Study First Received: | September 12, 2008 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00753740 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cancer Neoplasms Solid Tumor Ovarian Cancer Solid Malignancies |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Disease Progression Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |