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

NCT01867879 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-09-05

No results posted yet for this study

Summary

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

Conditions

  • Advanced Solid Tumors (Excluding Breast Cancer)

Interventions

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.

DRUG

Placebo

Placebo tablets, orally, single dose.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Johanna Bendell, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-08-31
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867879 on ClinicalTrials.gov