Status:
COMPLETED
Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Solid Tumors (Excluding Breast Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.
Detailed Description
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 inve...
Eligibility Criteria
Inclusion
- Has provided written informed consent
- Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- Has received no more than 5 prior cancer therapies
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Corrected QT interval using Bazett's correction is no more than 450 msec on resting ECG
- Has adequate organ function (bone marrow, kidney and liver)
- Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion
- Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- Certain serious illnesses or medical condition(s)
- Has a family history of unexplained sudden death or long QT syndrome
- Has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment
- Is a patient for whom it is not technically possible to obtain quality ECG tracings
- Is receiving a concomitant drug that is known to affect QT interval or to be arrhythmogenic
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Known sensitivity to TAS-102 or its components
- Is a pregnant or lactating female
- Refuses to use an adequate means of contraception (including male patients)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01867879
Start Date
June 1 2013
End Date
April 1 2015
Last Update
September 5 2024
Active Locations (1)
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1
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203