Spots Global Cancer Trial Database for Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)
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Trial Identification
Brief Title: Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)
Official Title: A Two-Part Phase 2/ 3 Multicentre, Double-Blind, Randomized, Placebo Controlled Study of Varlitinib Plus mFOLFOX6 Verses Placebo Plus mFOLFOX6 In Subjects With HER1/ HER2 Co Expressing Advanced or Metastatic Gastric Cancer Without Prior Exposure to Systemic Therapy
Study ID: NCT03130790
Conditions
Study Description
Brief Summary: This protocol for Varlitinib is developed for the treatment of Gastric 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 mFOLFOX6 for the treatment of Gastric Cancer. Treatment groups are Varlitinib+mFOLFOX6 and Placebo+mFOLFOX6.
Detailed Description: Phase 2 is planned to recruit approximately 50 or more eligible subjects in order to obtain data from 40 evaluable patients. Anticipated completion date in Dec 2018. Recruitment completed. Phase 3 is planned to recruit 350 patients. Anticipated completion date in Dec 2022. Not yet recruiting.
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
2 Sites, Tallinn, , Estonia
1 Site, Hong Kong, , Hong Kong
2 Sites, Daegu, , Korea, Republic of
1 Site, Incheon, , Korea, Republic of
1 Site, Jeongnam, , Korea, Republic of
11 Sites, Seoul, , Korea, Republic of
2 Sites, Suwon, , Korea, Republic of
2 Sites, Kaunas, , Lithuania
1 Site, Vilnius, , Lithuania
2 Sites, Kuala Lumpur, , Malaysia
1 Site, Singapore, , Singapore
1 Site, Kaohsiung, , Taiwan
1 Site, Taichung, , Taiwan
1 Site, Taipei, , Taiwan
1 Site, Khon Kaen, , Thailand
1 Site, Pathum Thani, , Thailand
Contact Details
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