Phase 1
Completed N=15
A Phase I Study of TAS-102 in Solid Tumors
Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov NCT02261532 ↗
Enrolled (actual)
15
Serious AEs
26.7%
Results posted
Oct 2024
Primary outcomePrimary: Cmax (Maximum Plasma Concentration) of FTD — 3019.49; 3693.08 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximum Plasma Concentration) of FTD |
3019.49; 3693.08 | — |
| PRIMARY Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD |
1.00; 2.61 | — |
| PRIMARY AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD |
7796.60; 18181.34 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02261532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.