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

Phase 1CompletedNCT03082053

ASLAN Pharmaceuticals24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Biliary Tract Cancer Advanced or Metastatic Solid Tumors

Interventions

varlitinibDRUG

IMP

capecitabineDRUG

Companion Medication

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (1)

ASLAN Selected sites

Tokyo, Japan

Outcomes

Primary Outcomes

The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle

Time frame: 3 weeks

Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.

Time frame: 52 weeks

Secondary Outcomes

Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)

Time frame: 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)

Time frame: Through, Day 1, Day 3, Day 22

Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)

Time frame: 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)

Time frame: Through, Day 1, Day 3, Day 22

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.