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A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone


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

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Trial Information

A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone


This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD
as a TAS-102 component compared with FTD alone in patients with advanced solid tumors
(excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102
or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during
the extension phase.


Inclusion Criteria:



1. Has provided written informed consent

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

3. ECOG performance status of 0 or 1

4. Is able to take medications orally

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

6. 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. 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 had either partial or total gastrectomy

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

5. Known sensitivity to TAS-102 or its components

6. Is a pregnant or lactating female

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

FTD pharmacokinetic parameters AUC0-last and Cmax

Outcome Time Frame:

Day 1 of Cycle 1

Safety Issue:

No

Principal Investigator

Drew Rasco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South Texas Accelerated Research Therapeutics, LLC

Authority:

United States: Food and Drug Administration

Study ID:

TPU-TAS-102-102

NCT ID:

NCT01867866

Start Date:

June 2013

Completion Date:

April 2014

Related Keywords:

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

Name

Location
South Texas Accelerated Research Therapeutics, Llc San Antonio, Texas  78229