A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours

Conditions
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Advanced or Metastatic Biliary Tract Cancer, Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Drug: varlitinib
* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 2 studies of single group in 1 protocol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study I<br>Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors | Drug: varlitinib<br>* IMP<br>* Other names: ASLAN001;|
| Experimental: Study II<br>Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer | Drug: varlitinib<br>* IMP<br>* Other names: ASLAN001;Drug: capecitabine<br>* Companion Medication<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle |  | 3 weeks | 
| Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax) |  | Through, Day 1, Day 3, Day 22 | 
| Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Area under the plasma concentration-time curve (AUC) from 0 to 12 hours (AUC0-12) |  | Through, Day 1, Day 3, Day 22 | 
| Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin) |  | Through, Day 1, Day 3, Day 22 | 
| Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β) |  | Through, Day 1, Day 3, Day 22 |