Spots Global Cancer Trial Database for Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma
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Trial Identification
Brief Title: Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma
Official Title: A Phase 2 Randomized, Double-Blind Study of Dalantercept and Axitinib Compared to Placebo and Axitinib in Patients With Advanced Renal Cell Carcinoma
Study ID: NCT01727336
Conditions
Study Description
Brief Summary: The purpose of Part 1 of this study is to evaluate the safety and tolerability of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (RCC) to determine the recommended dose level of dalantercept in combination with axitinib for Part 2. The purpose of Part 2 of this study is to determine whether treatment with dalantercept in combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone in patients with advanced renal cell carcinoma (RCC).
Detailed Description: In Part 1 of the study, groups of subjects received escalating doses of dalantercept; 0.6, 0.9 and 1.2 mg/kg in sequential groups. All subjects received concurrent axitinib 5 mg PO BID. A total of 29 subjects were enrolled i Part 1 of the study. In Part 2, dalantercept at 0.9 mg/kg once every 3 weeks plus axitinib 5 mg PO BID was compared to placebo plus axitinib 5 mg PO BID. A total of 131 subjects were enrolled in Part 2 for a total of 160 in the study
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Highlands Oncology Group, PA, Fayetteville, Arkansas, United States
University of California Irvine Medical Center, Irvine, California, United States
University of California, Los Angeles (UCLA) - Institute of Urologic Oncology, Los Angeles, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University of Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Loyola University Chicago, Chicago, Illinois, United States
Indiana University Health Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States
Beth Israel Deaconess Med Center, Boston, Massachusetts, United States
Lahey Hospital & Medical Center, Burlington, Massachusetts, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Cancer Center Hackensack UMC, Hackensack, New Jersey, United States
University of New Mexico, Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C., Albany, New York, United States
North Shore LIJ Center for Advance Medicine, Lake Success, New York, United States
Mem Sloan Kettering Cancer Center, New York, New York, United States
NYU Cancer Institute, New York, New York, United States
Levin Cancer Institute, Charlotte, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Northwest Cancer Specialists, P.C., Tualatin, Oregon, United States
Saint Luke's University Health Network, Bethlehem, Pennsylvania, United States
Penn State Milton S- Hershey Medical Center, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Texas Oncology-South Austin, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-El Paso Cancer Treatment Center Grandview, El Paso, Texas, United States
Texas Oncology - Memorial City, Houston, Texas, United States
Texas Oncology - Tyler and Longview, Tyler, Texas, United States
Shenandoah Oncology P.C., Winchester, Virginia, United States
University of Wisconsin, Carbone Cancer Center, Madison, Wisconsin, United States
Contact Details
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