TumorsPhase 1NCT00400023
A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors
A Phase 1 study testing S-1 and FT in people with Tumors, run by Taiho Oncology, Inc. at 3 sites in United States.
Trial summary
This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- S-1 and FT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to May 2007
- 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
- A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Has histologically or cytologically proven advanced solid tumors for which no standard therapy exists.
- Has provided written informed consent.
- Is 18 years of age or older.
- Is able to take medications orally.
- Has Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 (Appendix A, Performance Status).
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- Has adequate organ function as defined by the following criteria:
- Has transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying malignancy, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
- Has a total serum bilirubin ≤ 1.5 times ULN.
- Has an absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units [IU]).
- Has a platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).
- Has a hemoglobin value of ≥ 9.0 g/dL.
- Has a calculated creatinine clearance > 60 mL/min (by Cockcroft-Gault formula.76 See Appendix E).
- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Has had treatment with any of the following within the specified time frame prior to study drug administration:
- An investigational agent received either concurrently or within the last 30 days.
- Previous therapy for malignancy within 21 days, including any chemotherapy, immunotherapy, biologic or hormonal therapy (6 weeks for nitrosureas or mitomycin C).
- Previous radiotherapy within 14 days.
- Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
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- Has a serious illness or medical condition(s) including, but not limited to, the following:
- Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III or IV, see Appendix F).
- Known (at the time of entry) gastrointestinal disorder, including malabsorption,chronic nausea, vomiting, or diarrhea present to the extent that it might interfere with oral intake and absorption of the study medication.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- Known brain metastasis.
- Known leptomeningeal metastasis.
- Manifest ascites.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Is receiving a concomitant treatment with drugs interacting with S-1 or FT. The following drugs are prohibited because there may be an interaction with S-1 or FT:
- Sorivudine, uracil, dipyridamole, cimetidine and folinic acid (may enhance S-1 or FT activity).
- Allopurinol (may diminish S-1 or FT activity).
- Phenytoin (S-1 or FT may enhance phenytoin activity).
- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 or FT, and flucytosine activity).
- Pilocarpine (may inhibit CYP2A6 activity).
- Has sensitivity to 5-FU.
- Is a pregnant or lactating female.
- Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients). 3.3.3 Discontinuation Criteria Clearly document the reason for the patient's discontinuation in the patient's source documents and on the CRF. Discontinue the patient from study if any of the following occur:
- Patient withdraws consent.
- Patient has toxicities that, in the opinion of the Investigator, require the patient's discontinuation.
- Patient has an intercurrent illness that in the opinion of the Investigator requires the patient's discontinuation.
- The Investigator concludes that it is in the patient's best interest to discontinue therapy.
- Patient is willingly or inadvertently noncompliant in the opinion of the Investigator and requires the patient to be discontinued.
- During optional Extension Phase, the patient has objective PD (defined by imaging studies or clinical evaluation). g. During optional Extension Phase, the patient requires a recovery period of > 4 weeks (ie, more than 3 weeks from the scheduled start date of the next cycle; see Section 4.5.4.1.1).
- The patient completes the Cross-Over Pharmacokinetic Phase but does not choose to enter the optional S-1 Extension Phase.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Yale Cancer Center
New Haven, Connecticut, 06520
Premiere Oncology, A Medical Corporation
Santa Monica, California, 90404
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
About this study
Official title: A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of the Dihydropyrimidine Dehydrogenase (Dpd) Inhibitory Action of 5-Chloro-2,4-Dihydroxypyridine (Cdhp) as an S-1 Component
This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be conducted in 2 parts (Cross-Over Pharmacokinetic Phase and S-1 Extension Phase).
- Conditions
- Tumors
- Being tested
- S-1, FT
- Keywords
- Advanced Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.
During the S-1 Extension Phase (Part 2), S-1 30 mg/m2 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks.
FTDrug
During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive one of the following treatment sequences:
* Sequence A: Single dose of 50 mg S-1 (2 capsules of 25 mg) on Day 1 followed by a single dose of 800 mg FT (8 capsules of 100 mg) on Day 8
* Sequence B: Single dose of 800 mg FT on Day 1 followed by a single dose of 50 mg S-1 on Day 8 Receives: Drug: S-1 |
| 2 | Active comparator | During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive one of the following treatment sequences:
* Sequence A: Single dose of 50 mg S-1 (2 capsules of 25 mg) on Day 1 followed by a single dose of 800 mg FT (8 capsules of 100 mg) on Day 8
* Sequence B: Single dose of 800 mg FT on Day 1 followed by a single dose of 50 mg S-1 on Day 8 Receives: Drug: FT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-Over Pharmacokinetic Phase: To compare plasma concentrations, investigate the plasma and urine pharmacokinetic profiles, and to evaluate the duration of DPD inhibition after the administration of S-1
Measured: The Cross-Over Pharmacokinetic phase (Part 1) will last 11 days
S-1 Extension Phase: Efficacy (antitumor response)
Measured: Each cycle of the S-1 Extension Phase (Part 2) will be 21 days (14 days S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
S-1 Extension Phase: Safety (Adverse events, lab assessments)
Measured: Each cycle of the S-1 Extension Phase (Part 2) will be 21 days (14 days S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
S-1 Extension Phase: Pharmacokinetic profiles of the components of S-1 and their metabolites, and duration of DPD inhibition after administration of multiple doses (end of Cycle 1)
Measured: Each cycle of the S-1 Extension Phase (Part 2) will be 21 days (14 days S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400023
- Sponsor's protocol ID
- TPU-S1108
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2006
- Last updated
- 3 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of the Dihydropyrimidine Dehydrogenase (Dpd) Inhibitory Action of 5-Chloro-2,4-Dihydroxypyridine (Cdhp) as an S-1 Component
- ClinicalTrials.gov ID
- NCT00400023
- Acronym / sponsor ID
- TPU-S1108
- Conditions
- Tumors
- Keywords
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 16 Nov 2006 (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.
This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be conducted in 2 parts (Cross-Over Pharmacokinetic Phase and S-1 Extension Phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive one of the following treatment sequences: * Sequence A: Single dose of 50 mg S-1 (2 capsules of 25 mg) on Day 1 followed by a single dose of 800 mg FT (8 capsules of 100 mg) on Day 8 * Sequence B: Single dose of 800 mg FT on Day 1 followed by a single dose of 50 mg S-1 on Day 8 |
| 2 | Active comparator | Drug: FTDuring the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive one of the following treatment sequences: * Sequence A: Single dose of 50 mg S-1 (2 capsules of 25 mg) on Day 1 followed by a single dose of 800 mg FT (8 capsules of 100 mg) on Day 8 * Sequence B: Single dose of 800 mg FT on Day 1 followed by a single dose of 50 mg S-1 on Day 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Has histologically or cytologically proven advanced solid tumors for which no standard therapy exists.
- Has provided written informed consent.
- Is 18 years of age or older.
- Is able to take medications orally.
Key exclusion criteria (30 listed)
- Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Has had treatment with any of the following within the specified time frame prior to study drug administration:
- Has a serious illness or medical condition(s) including, but not limited to, the following:
- Is receiving a concomitant treatment with drugs interacting with S-1 or FT. The following drugs are prohibited because there may be an interaction with S-1 or FT:
- Has sensitivity to 5-FU.
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 |
|---|---|---|
| S-1During the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose. During the S-1 Extension Phase (Part 2), S-1 30 mg/m2 will be administered orally BID for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks. | Drug | 1 |
| FTDuring the Cross-Over PK Phase, S-1 will be administered as a 50 mg oral fixed dose and FT will be administered as an 800 mg oral fixed dose. | Drug | 2 |
Primary outcome
Cross-Over Pharmacokinetic Phase: To compare plasma concentrations, investigate the plasma and urine pharmacokinetic profiles, and to evaluate the duration of DPD inhibition after the administration of S-1
Time frame: The Cross-Over Pharmacokinetic phase (Part 1) will last 11 days
S-1 Extension Phase: Efficacy (antitumor response)
Time frame: Each cycle of the S-1 Extension Phase (Part 2) will be 21 days (14 days S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
S-1 Extension Phase: Safety (Adverse events, lab assessments)
Time frame: Each cycle of the S-1 Extension Phase (Part 2) will be 21 days (14 days S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
S-1 Extension Phase: Pharmacokinetic profiles of the components of S-1 and their metabolites, and duration of DPD inhibition after administration of multiple doses (end of Cycle 1)
Time frame: Each cycle of the S-1 Extension Phase (Part 2) will be 21 days (14 days S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
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 3 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-1 and FT in people with Tumors, run by Taiho Oncology, Inc. at 3 sites 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 14 inclusion and 30 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 3 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 3 sites 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?
Cross-Over Pharmacokinetic Phase: To compare plasma concentrations, investigate the plasma and urine pharmacokinetic profiles, and to evaluate the duration of DPD inhibition after the administration of S-1 (time frame: The Cross-Over Pharmacokinetic phase (Part 1) will last 11 days). The study lists 4 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 3 Sep 2024.