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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03082053

Enrollment

Registered

2017-03-17

Start date

2017-01-31

Completion date

2018-06-06

Last updated

2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Biliary Tract Cancer, Advanced or Metastatic Solid Tumors

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.

Interventions

DRUGvarlitinib

IMP

DRUGcapecitabine

Companion Medication

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

2 studies of single group in 1 protocol

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026