Advanced or Metastatic Solid Tumors
Conditions
Brief summary
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
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.
Interventions
DRUGTAS-102
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.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (Maximum Plasma Concentration) of FTD | Multiple time points on Day 1 and Day 12 of Cycle 1. |
| Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | 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 | Multiple time points on Day 1 and Day 12 of Cycle 1. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAS-102 TAS-102: 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | TAS-102 |
|---|---|
| Age, Continuous | 56.0 years |
| Region of Enrollment China | 15 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 14 / 15 |
| serious Total, serious adverse events | 4 / 15 |
Outcome results
Primary
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-102 | AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD | Day 1 | 7796.60 ng·hr/mL | Geometric Coefficient of Variation 19.1 |
| TAS-102 | AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD | Day 12 | 18181.34 ng·hr/mL | Geometric Coefficient of Variation 30 |
Primary
Cmax (Maximum Plasma Concentration) of FTD
Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-102 | Cmax (Maximum Plasma Concentration) of FTD | Day 1 | 3019.49 ng/mL | Geometric Coefficient of Variation 34 |
| TAS-102 | Cmax (Maximum Plasma Concentration) of FTD | Day 12 | 3693.08 ng/mL | Geometric Coefficient of Variation 21.7 |
Primary
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-102 | Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | Day 1 | 1.00 hours | Geometric Coefficient of Variation 58.7 |
| TAS-102 | Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD | Day 12 | 2.61 hours | Geometric Coefficient of Variation 36.2 |