Back to resultsA Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
Primary Purpose
Advanced or Metastatic Biliary Tract Cancer, Advanced or Metastatic Solid Tumors
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
varlitinib
capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced or Metastatic Biliary Tract Cancer
Eligibility Criteria
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)
Sites / Locations
- ASLAN Selected sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study I
Study II
Arm Description
Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors
Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
Outcomes
Primary Outcome Measures
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.
Secondary Outcome Measures
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)
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)
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03082053
Brief Title
A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
Official Title
A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
June 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASLAN Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Biliary Tract Cancer, Advanced or Metastatic Solid Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
2 studies of single group in 1 protocol
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study I
Arm Type
Experimental
Arm Description
Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors
Arm Title
Study II
Arm Type
Experimental
Arm Description
Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer
Intervention Type
Drug
Intervention Name(s)
varlitinib
Other Intervention Name(s)
ASLAN001
Intervention Description
IMP
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Companion Medication
Primary Outcome Measure Information:
Title
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
Time Frame
3 weeks
Title
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)
Time Frame
Through, Day 1, Day 3, Day 22
Title
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)
Time Frame
Through, Day 1, Day 3, Day 22
Title
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)
Time Frame
Through, Day 1, Day 3, Day 22
Title
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β)
Time Frame
Through, Day 1, Day 3, Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
ASLAN Selected sites
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
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