TreeTopp : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

Two/ThreePhase Two/Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractBile duct

Trial Overview Read MoreRead more

This phase II/III trial is evaluating two oral drugs (Varlitinib and Capecitabine) in the treatment of Biliary Tract Cancer.
 

This trial is treating patients with Biliary Tract Cancer.

This is a systemic therapy trial .

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific 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

Commercial Sponsor

Aslan Pharmaceuticals

Summary

Participants in this trial will be randomized into one of two cohorts. In the experimental cohort, participants will receive Varlitinib (300mg, oral tablets twice daily) and Capecitabine (1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles) until disease progression, toxicity, withdrawal of consent or death. In the comparator group, participants will receive Capecitabine (as above) and a placebo (oral tablet, twice daily) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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