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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03082053
Other study ID # ASLAN001-010
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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