A Phase I Study of TAS-102 in Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors

NCT06172309

Advanced Solid Tumors

COMPLETED PHASE1

STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

NCT04635631

Neoplasms

COMPLETED PHASE1

A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

NCT01610479

Advanced Solid Tumors

COMPLETED PHASE1

Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors

NCT05839106

Advanced Tumor

RECRUITING PHASE1/PHASE2

Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

NCT01863485

Advanced Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced or Metastatic Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAS-102

Group Type EXPERIMENTAL

TAS-102

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No