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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors (Excluding Breast Cancer)

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Trial Information

A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered 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).


Inclusion Criteria:



1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy
exists

3. Has received no more than 5 prior cancer therapies

4. ECOG performance status of 0 or 1

5. Is able to take medications orally

6. Corrected QT interval using Bazett's correction is no more than 450 msec on resting
ECG

7. Has adequate organ function (bone marrow, kidney and liver)

8. 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 Criteria:

1. 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

2. Certain serious illnesses or medical condition(s)

3. Has a family history of unexplained sudden death or long QT syndrome

4. Has had a documented cardiovascular complication following a fluoropyrimidine-derived
treatment

5. Is a patient for whom it is not technically possible to obtain quality ECG tracings

6. Is receiving a concomitant drug that is known to affect QT interval or to be
arrhythmogenic

7. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any
prior therapies

8. Known sensitivity to TAS-102 or its components

9. Is a pregnant or lactating female

10. Refuses to use an adequate means of contraception (including male patients)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

QTc interval

Outcome Description:

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)

Outcome Time Frame:

Days -2, -1, 1, and 12 of Cycle 1

Safety Issue:

Yes

Principal Investigator

Johanna Bendell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

TPU-TAS-102-103

NCT ID:

NCT01867879

Start Date:

June 2013

Completion Date:

July 2014

Related Keywords:

  • Advanced Solid Tumors (Excluding Breast Cancer)
  • Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
  • Breast Neoplasms
  • Neoplasms

Name

Location

Sarah Cannon Research InstituteNashville, Tennessee  37203