NCT03093870

Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: ASLAN Pharmaceuticals · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Varlitinib	Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
DRUG	Capecitabine	1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
DRUG	Placebo (for Varlitinib)	oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death

Timeline

• Start date: 2017-07-04
• Primary completion: 2019-11-12
• Completion: 2020-04-17
• First posted: 2017-03-28
• Last updated: 2021-08-03
• Results posted: 2021-08-03

Locations

21 sites across 11 countries: United States, Australia, China, Hong Kong, Hungary, Japan, Poland, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study