MedTrace Logo

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

NCT03093870 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-08-03

Study results available
· View outcomes & findings →

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

Conditions

  • Biliary Tract Cancer

Interventions

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

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • CMIC Co, Ltd. Japan

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • ASLAN Pharmaceuticals

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-04
Primary Completion
2019-11-12
Completion
2020-04-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Hong Kong
  • Hungary
  • Japan
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093870 on ClinicalTrials.gov