drugset / Trial / NCT03093870
Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer
Phase 2/3
Completed
151 enrolled
ASLAN Pharmaceuticals
CMIC Co, Ltd. Japan · collabSyneos Health · collabbioRASI, LLC · collab
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2017-07-04
- Primary completion
- 2019-11-12
- Completion
- 2020-04-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varlitinib | Small molecule | 300 mg | Oral |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |