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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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