Advanced Solid Tumors (Excluding Breast Cancer)Phase 1NCT01874522
Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI
A Phase 1 study testing TAS-102 tablets and TAS-102 oral solution in people with Advanced Solid Tumors (Excluding Breast Cancer), run by Taiho Oncology, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors (Excluding Breast Cancer)
- What is being tested?
- TAS-102 tablets and TAS-102 oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- TAS-102 tablets, TAS-102 oral solution
- Keywords
- Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 oral solutionDrug
60 mg/dose, orally, up to 2 single doses separated by 1-week washout
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 tablets | Experimental | Not described Receives: Drug: TAS-102 tablets |
| TAS-102 oral solution | Experimental | Not described Receives: Drug: TAS-102 oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: 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
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: Day 1 of Periods 1, 2, and 3
CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: Day 1 of Periods 1, 2, and 3
Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: Day 1 of Periods 1, 2, and 3
Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: Day 1 of Periods 1, 2, and 3
AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: Day 1 of Periods 1, 2, and 3
AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Measured: Day 1 of Periods 1, 2, and 3
Safety monitoring including adverse events, vital signs, and laboratory assessments
Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
Measured: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors (Excluding Breast Cancer)Studies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Von Hoff, MD, Principal investigator, Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874522
- Sponsor's protocol ID
- TPU-TAS-102-104
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2013
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01874522
- Acronym / sponsor ID
- TPU-TAS-102-104
- Keywords
- Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-102 tablets | Experimental | Drug: TAS-102 tablets |
| TAS-102 oral solution | Experimental | Drug: TAS-102 oral solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-102 tabletsCrossover 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. | Drug | TAS-102 tablets |
| TAS-102 oral solution60 mg/dose, orally, up to 2 single doses separated by 1-week washout | Drug | TAS-102 oral solution |
Primary outcome
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.
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.
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.
9 secondary outcomes
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
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
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
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
Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution
Time frame: 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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Von Hoff, MD principal investigator
Scottsdale Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS-102 tablets and TAS-102 oral solution in people with Advanced Solid Tumors (Excluding Breast Cancer), run by Taiho Oncology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.