A Phase I Study of TAS-102 in Solid Tumors

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.

Detailed Description
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This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.

Official Title
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A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors

Conditions
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Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Drug: TAS-102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Has provided written informed consent prior to performance of any study procedure. 2. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor. 3. Is able to take medications orally. 4. Has adequate organ function (bone marrow, kidney and liver). 5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Has received TAS-102. 2. Has suffered serious complications. 3. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies. 4. Has had prior gastrectomy. 5. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-102<br> | Drug: TAS-102<br>* TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum plasma concentration) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| Tmax (time to reach maximum drug concentration in blood) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| AUC0-t (area under the plasma concentration versus time curve from time 0 to time (t) of the last quantifiable concentration ) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| AUC0-10 (area under the plasma concentration versus time curve from time 0 to 10 hours post dose) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| AUCinf (area under the plasma concentration versus time curve from time 0 to infinity) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| T½ (half-life) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| CL/F (oral clearance) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 
| Vd/F (apparent volume of distribution) of FTD and TPI |  | Multiple time points on Day 1 and Day 12 of Cycle 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety |  | Through 30 days following last administration of study medication. | 
| Antitumor Activity (Response Rate) |  | Average 8 weeks from Cycle 1 Day 1. |