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

June 27, 2018 updated by: ASLAN Pharmaceuticals

A Phase Ib 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • ASLAN Selected sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study I
Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors
Drug: varlitinib
IMP
Other Names:
  • ASLAN001
Experimental: Study II
Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
Drug: varlitinib
IMP
Other Names:
  • ASLAN001
Drug: capecitabine
Companion Medication
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
Time Frame: 3 weeks
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
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)
Time Frame: Through, Day 1, Day 3, Day 22
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
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
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
Through, Day 1, Day 3, Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASLAN Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2017

Primary Completion (Actual)

December 7, 2017

Study Completion (Actual)

June 6, 2018

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASLAN001-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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