Spots Global Cancer Trial Database for Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
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Trial Identification
Brief Title: Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
Official Title: A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
Study ID: NCT00940225
Study Description
Brief Summary: This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.
Detailed Description: The goal of this clinical trial was to learn about the efficacy, safety, and tolerability of cabozantinib against a placebo in subjects with Metastatic Breast Cancer (MBC), Gastric and Gastroesophageal Junction Cancer (GEJ), Hepatocellular Carcinoma (HCC), Melanoma, Non-small Cell Lung Cancer (NSCLC), Ovarian (primary peritoneal or fallopian tube carcinoma), Pancreatic Cancer, Castration-Resistant Prostate Cancer (CRPC), or Small cell Lung Cancer (SCLC) with advanced tumors. The main questions this study aimed to answer were: * What is the efficacy of cabozantinib in subjects with advanced solid tumors? * What is the safety and efficacy of cabozantinib at two starting dose levels 100 milligrams (mg) once daily (po QD) and 39.4 mg po QD? Please note: that the 39.4 mg, po QD was only used in the Non-Randomized Expansion (NRE) part of the study There were three stages to the Randomized Discontinuation Trial (RDT): 1. The Lead in Stage: This stage enrolled eligible patients with advanced solid tumors who received open-label cabozantinib at 100 mg once daily for 12 weeks. 2. The Randomized Stage: Subjects who demonstrated stable disease (SD) at the end of 12 weeks of the Lead-in Stage were randomized to receive cabozantinib or placebo (a look-alike substance that contains no active drug) in a blinded manner. After randomization, when a patient developed progressive disease (PD), study treatments were discontinued and the treatment blind was broken. If the subject was on a placebo, the subject was offered the opportunity to receive cabozantinib. If the subject was already on cabozantinib, the subject entered the Post-Treatment Period where they were followed until death. 3. Open-Label Extension: Subjects who were deemed with partial response (PR) or complete response (CR) at Week 12 of the Lead-In Stage were not randomized but allowed to participate in the "Open Label Extension". Patients were given the cabozantinib treatment of 100 mg, po QD. The emerging data supported enrollment in an open-label, Non-Randomized Expansion cohort (NRE). These cohorts targeted patients with prostate and ovarian cancers. For the patients with prostate, they were assigned to either 100 mg, po QD or 39.4 mg, po QD.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pinnacle Oncology of Arizona, Scottsdale, Arizona, United States
University of California Davis Cancer Center, Sacramento, California, United States
University of California, San Francisco, San Francisco, California, United States
Stanford University Medical Center, Stanford, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Medical College of Georgia, Augusta, Georgia, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Dana Farber Cancer Center, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Wayne State University, Detroit, Michigan, United States
University of Missouri Health Care, Columbia, Missouri, United States
Kansas City Cancer Center, Lee's Summit, Missouri, United States
Midwest Hematology Oncology Consultants, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
NYU Clinical Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University GYN Oncology, Hilliard, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Northwest Cancer Specialists, Tualatin, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas, ITOR, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - Central Austin Cancer Center, Austin, Texas, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
University of Texas, M. D., Anderson Cancer Center, Houston, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Fairfax Northern Virginia Hematology Oncology, Fairfax, Virginia, United States
University of Washington, Seattle, Washington, United States
One Study Location, Brussels, , Belgium
One Study Location, Jette, , Belgium
Multiple Study Locations, Leuven, , Belgium
, Liege, , Belgium
One Study Location, Mons, , Belgium
One Study Location, Jerusalem, , Israel
One Study Location, Tel Aviv, , Israel
One Study Location, Tel-Hashomer, , Israel
One Study Location, Zerifin, , Israel
Multiple Study Locations, Tainan City, , Taiwan
Chang Gung Medical Foundation, Taoyuan County, Taipei, , Taiwan
, Taipei, , Taiwan
One Study Location, London, , United Kingdom
Contact Details
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