Clinical trial · Interventional
A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
NCT03082053CI-TRIAL-00033509completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Biliary Tract Cancer | — | UNRESOLVED | — |
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| varlitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study I
- description
- Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors
- interventionNames
- Drug: varlitinib
- type
- EXPERIMENTAL
- label
- Study II
- description
- Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
- interventionNames
- Drug: varlitinib
- Drug: capecitabine
Primary outcomes (2)
- measure
- The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage * Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma) Exclusion Criteria: * Subjects with concurrent multiple primary cancers. * Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease * Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
References
Publications (0)
Data not yet available
No reference posted for this study.