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

Phase 1

Completed

• Conditions: Advanced or Metastatic Biliary Tract Cancer; Advanced or Metastatic Solid Tumors
• Interventions: Drug: varlitinib; Drug: capecitabine

• Registration Number: NCT03082053
• Lead Sponsor: ASLAN Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-17
• Primary Completion: 2017-12-07
• Status Verified: 2018-06
• Study Completion: 2018-06-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Study II	capecitabine	Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
Study II	varlitinib	Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
Study I	varlitinib	Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

ASLAN Selected sites; 🇯🇵 Tokyo, Japan