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

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082053
• Other study ID #: ASLAN001-010
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2017
• Est. completion date: June 6, 2018

Study information

• Verified date: June 2018
• Source: Aslan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 6, 2018
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced or Metastatic Biliary Tract Cancer
• Advanced or Metastatic Solid Tumors
• Biliary Tract Neoplasms

Intervention

Drug:
• varlitinib
IMP
• capecitabine
Companion Medication

Locations

Country	Name	City	State
Japan	ASLAN Selected sites	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Aslan Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle		3 weeks
Primary	Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.		52 weeks
Secondary	Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)		Through, Day 1, Day 3, Day 22
Secondary	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
Secondary	Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)		Through, Day 1, Day 3, Day 22
Secondary	Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase ß (t1/2ß)		Through, Day 1, Day 3, Day 22