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Completed

NCT Number: NCT03082053

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

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.

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Key information

Conditions

Advanced or Metastatic Biliary Tract Cancer Advanced or Metastatic Solid Tumors Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ASLAN Selected sites

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Varlitinib

Drug

IMP

Other names: ASLAN001

Capecitabine

Drug

Companion Medication

Other names: Xeloda

Primary outcomes

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

    Time frame: 3 weeks

  2. 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

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

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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

ASLAN Pharmaceuticals

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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