Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

August 30, 2024 updated by: Taiho Oncology, Inc.

A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of FTD and TPI

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, open-label, randomized, 2-sequence, 3-period crossover study evaluating the relative bioavailability of TAS-102 tablets compared to an oral solution in patients with advanced solid tumors. This study will be conducted in 2 parts. The crossover bioavailability part will be followed by an extension conducted with TAS-102 tablets only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAS-102 tablets
Drug: TAS-102 tablets

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.
Experimental: TAS-102 oral solution
Drug: TAS-102 oral solution
60 mg/dose, orally, up to 2 single doses separated by 1-week washout

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)
Time Frame: Day 1 of Periods 1, 2, and 3
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)
Time Frame: Day 1 of Periods 1, 2, and 3
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 )
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety monitoring including adverse events, vital signs, and laboratory assessments
Time Frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
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
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution
Time Frame: Day 1 of Periods 1, 2, and 3
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Day 1 of Periods 1, 2, and 3
Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Every 8 weeks during the extension period through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met.
Every 8 weeks during the extension period through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taiho Oncology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Von Hoff, MD, Scottsdale Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TPU-TAS-102-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumors (Excluding Breast Cancer)

Clinical Trials on TAS-102 tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings