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

Aslan Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced or Metastatic Biliary Tract Cancer; Advanced or Metastatic Solid Tumors

Treatments: Drug: varlitinib; Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03082053

ASLAN001-010

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Study I

Experimental group

Description:

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

Treatment:

Drug: varlitinib

Study II

Experimental group

Description:

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

Treatment:

Drug: capecitabine

Drug: varlitinib