NCT01874522

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

June 4, 2013

Last Update Submit

August 30, 2024

Conditions

Advanced Solid Tumors (Excluding Breast Cancer)

Keywords

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

Outcome Measures

Primary Outcomes (3)

  • Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)

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

    Day 1 of Periods 1, 2, and 3

  • Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-last)

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

    Day 1 of Periods 1, 2, and 3

  • Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-inf )

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

    Day 1 of Periods 1, 2, and 3

Secondary Outcomes (9)

  • Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution

    Day 1 of Periods 1, 2, and 3

  • T1/2 of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution

    Day 1 of Periods 1, 2, and 3

  • CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution

    Day 1 of Periods 1, 2, and 3

  • Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution

    Day 1 of Periods 1, 2, and 3

  • Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution

    Day 1 of Periods 1, 2, and 3

  • +4 more secondary outcomes

Study Arms (2)

TAS-102 tablets

EXPERIMENTAL
Drug: TAS-102 tablets

TAS-102 oral solution

EXPERIMENTAL
Drug: TAS-102 oral solution

Interventions

TAS-102 tabletsDRUG

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
TAS-102 oral solutionDRUG

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

TAS-102 oral solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has provided written informed consent
  • Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
  • ECOG performance status of 0 or 1
  • Is able to take medications orally
  • 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.

You may not qualify if:

  • Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
  • Certain serious illnesses or medical condition(s)
  • Has had either partial or total gastrectomy
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Interventions

trifluridine tipiracil drug combination

Study Officials

  • Daniel Von Hoff, MD

    Scottsdale Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 11, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

September 5, 2024

Record last verified: 2024-08

Locations

US(1)