NCT03082053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

February 2, 2017

Last Update Submit

June 27, 2018

Conditions

Advanced or Metastatic Biliary Tract CancerAdvanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Study I

EXPERIMENTAL

Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors

Drug: varlitinib

Study II

EXPERIMENTAL

Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer

Drug: varlitinibDrug: capecitabine

Interventions

varlitinibDRUG

IMP

Also known as: ASLAN001
Study IStudy II
capecitabineDRUG

Companion Medication

Also known as: Xeloda
Study II

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASLAN Selected sites

Tokyo, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 2 studies of single group in 1 protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

March 17, 2017

Study Start

January 31, 2017

Primary Completion

December 7, 2017

Study Completion

June 6, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)