A Phase I Study of TAS-102 in Solid Tumors

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261532
• Other study ID #: 10040100
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2014
• Last updated: August 2, 2017
• Start date: September 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Taiho Pharmaceutical Co., Ltd selected site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum plasma concentration) of FTD and TPI		Multiple time points on Day 1 and Day 12 of Cycle 1.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	T½ (half-life) of FTD and TPI		Multiple time points on Day 1 and Day 12 of Cycle 1.
Primary	CL/F (oral clearance) of FTD and TPI		Multiple time points on Day 1 and Day 12 of Cycle 1.
Primary	Vd/F (apparent volume of distribution) of FTD and TPI		Multiple time points on Day 1 and Day 12 of Cycle 1.
Secondary	Number of participants with adverse events as a measure of safety		Through 30 days following last administration of study medication.
Secondary	Antitumor Activity (Response Rate)		Average 8 weeks from Cycle 1 Day 1.