Spots Global Cancer Trial Database for Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
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Trial Identification
Brief Title: Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Varlitinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as Second Line Systemic Therapy
Study ID: NCT03093870
Conditions
Study Description
Brief Summary: This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine
Detailed Description: Part 1 of study(Phase 2) is planned to have 120 patients and anticipated completion on July 2019. Recruitment completed. Part 2 of study(Phase 3) is planned to have 350 patients and anticipated completion on Dec 2022. Not yet recruiting.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Karmanos Cancer Institute/Wayne State University, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
CCCN, Las Vegas, Nevada, United States
Ruttenberg Cancer Center, Mount Sinai Hospital, New York, New York, United States
Levine Cancer Institute, Carolinas Healthcare System, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology, P.A., Dallas, Texas, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
There are 5 sites in different cities in Australia, Camperdown, , Australia
There are 6 sites in different cities in China, Nanjing, Nanjing, China
There are 2 sites in Hong Kong, Hong Kong, , Hong Kong
There are 2 sites in Hungary, Budapest, , Hungary
There are 7 sites in different cities in Japan, Chiba, , Japan
There are 15 sites in different cities in South Korea, Seoul, , Korea, Republic of
There are 2 sites in different cities in Poland, Otwock, , Poland
There are 2 sites in Singapore., Singapore, , Singapore
There are 5 sites in different cities in Spain, Barcelona, , Spain
There are 5 sites in different cities in Taiwan, Taipei, , Taiwan
Contact Details
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