Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

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.

TAS-102

Placebo

Johanna Bendell, MD

The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.

This is a Phase 1, nonrandomized study to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors. The study is conducted in 2 phases: the cardiac safety evaluation phase to investigate cardiac repolarization and the cardiac safety profile (Cycle 1) and the extension phase to assess the safety profile and antitumor activity (subsequent cycles).

Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors

Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1)

Predose (Day -2) to postdose changes and absolute values in quantitative Holter ECG parameters (heart rate, RR, PR and QRS intervals) after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1). In addition, qualitative assessments of Holter ECG recordings will be performed.

Pharmacokinetic samples are taken on Days 1 and 12 of Cycle 1. The relationship between plasma concentrations of TAS-102 and the change from baseline in QTc adjusted by placebo will be quantified using a linear mixed effect model approach.

Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

Taiho Oncology, Inc.

Breast Diseases

Skin Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Crossover bioavailability part: 60 mg/dose, orally, up to 2 single doses separated by 1-week washout.

Extension part: 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.

TAS-102 tablets

60 mg/dose, orally, up to 2 single doses separated by 1-week washout

TAS-102 oral solution

Daniel Von Hoff, MD

The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.

This is a Phase 1, open-label, randomized, 2-sequence, 3-period crossover study evaluating the relative bioavailability of TAS-102 tablets compared to an oral solution in patients with advanced solid tumors. This study will be conducted in 2 parts. The crossover bioavailability part will be followed by an extension conducted with TAS-102 tablets only.

Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of FTD and TPI

Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors	NCT01867879	Advanced Solid ...	TAS-102 Placebo	18 Years -	Taiho Oncology, Inc.
Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors	NCT01867879	Advanced Solid ...	TAS-102 Placebo	18 Years -	Taiho Oncology, Inc.
Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI	NCT01874522	Advanced Solid ...	TAS-102 tablets TAS-102 oral so...	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for advanced solid tumors (excluding breast cancer)