Advanced Solid TumorsPhase 1NCT01867866
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
A Phase 1 study testing TAS-102 and Trifluridine in people with Advanced Solid Tumors, run by Taiho Oncology, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TAS-102 and Trifluridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2016
- 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.
United States1 site
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
Read the detailed description
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- TAS-102, Trifluridine
- 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-102Drug
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.
TrifluridineDrug
35 mg/m2, orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 | Experimental | Not described Receives: Drug: TAS-102 |
| FTD (Trifluridine) | Experimental | Not described Receives: Drug: Trifluridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
FTD pharmacokinetic parameters AUC0-last and Cmax
Measured: Day 1 of Cycle 1
Secondary outcomes (5)
FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
Measured: Day 1 of Cycle 1
FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
Measured: Day 1 of Cycle 1
Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2
Measured: Day 12 of Cycles 1, 2, and 3
Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Every 8 weeks 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.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Drew Rasco, MD, Principal investigator, South Texas Accelerated Research Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867866
- Sponsor's protocol ID
- TPU-TAS-102-102
- Status last verified
- Aug 2024
- First submitted
- 24 May 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, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone
- ClinicalTrials.gov ID
- NCT01867866
- Acronym / sponsor ID
- TPU-TAS-102-102
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 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 pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-102 | Experimental | Drug: TAS-102 |
| FTD (Trifluridine) | Experimental | Drug: Trifluridine |
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-10235 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 |
| Trifluridine35 mg/m2, orally, single dose | Drug | FTD (Trifluridine) |
Primary outcome
FTD pharmacokinetic parameters AUC0-last and Cmax
Time frame: Day 1 of Cycle 1
5 secondary outcomes
FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
Time frame: Day 1 of Cycle 1
FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
Time frame: Day 1 of Cycle 1
Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2
Time frame: Day 12 of Cycles 1, 2, and 3
Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Every 8 weeks 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.
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
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.
Drew Rasco, MD principal investigator
South Texas Accelerated Research Therapeutics, LLC
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 and Trifluridine in people with Advanced Solid Tumors, 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?
FTD pharmacokinetic parameters AUC0-last and Cmax (time frame: Day 1 of Cycle 1). 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.