Impaired Hepatic FunctionPhase 1NCT00398424
Evaluating Patients With Impaired Hepatic Function
A Phase 1 study testing S-1/Cisplatin in people with Impaired Hepatic Function, run by Taiho Oncology, Inc. at 6 sites in United States.
Trial summary
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Hepatic Function
- What is being tested?
- S-1/Cisplatin
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2006to Mar 2009
- 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 0 to ≤ 2 (Appendix A, ECOG Performance Status).
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- Has adequate organ function as defined by the following criteria:
- 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
- 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:
- Any 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 nitrosoureas or mitomycin C).
- Previous radiotherapy within 14 days.
- Current enrollment in another clinical trial.
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- Required shunting or stenting of the liver within prior 28 days or planned during the first study treatment cycle.
- 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, NYHA Classification).
- 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.
- Previous organ allograft, including liver transplantation.
- Known brain metastasis.
- Known leptomeningeal metastases.
- Manifest ascites.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- 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. • 3. Is receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
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- Sorivudine, uracil, dipyridamole, cimetidine and folinic acid (may enhance S-1 activity).
- Allopurinol (may diminish S-1 activity).
- Phenytoin (S-1 may enhance phenytoin activity).
- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 and flucytosine activity).
- Pilocarpine (may inhibit CYP2A6 activity).
- 4. Has known sensitivity to 5-FU. 5. Is a pregnant or lactating female. 6. Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation
Lexington, Kentucky, 40536
Yale Cancer Center
New Haven, Connecticut, 06520
The Institute for Drug Development
San Antonio, Texas, 78245
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe.
Six patients will be enrolled inot each cohort and receive S-1.
- Conditions
- Impaired Hepatic Function
- Being tested
- S-1/Cisplatin
- Keywords
- Impaired Hepatic Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1/CisplatinDrug
PK Phase (Part 1), Beginning on Day 1 of the Pharmacokinetic Phase, 30 mg/m2 S-1 will be administered orally BID for 14 days (Days 1 through 14), followed by a 1-week recovery period.
On Day -2 and Day 14 of the Pharmacokinetic Phase, all patients will receive a single dose of 30 mg/m2 S-1 administered orally.
Extension Phase, Patients will receive S-1 at the dose that they tolerated in the PK Phase. S-1 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide specific dosing recommendations for S-1 in patients with hepatic impairment based on the PK of S-1 and its components after single dose and during steady state condition
Measured: The Pharmacokinetic Phase (Part 1) of the study will last 24 days.
Secondary outcomes (1)
To assess the antitumor activity and safety profile of S-1 in patients with impaired hepatic function
Measured: Each cycle of the Extension Phase (Part 2) will be 21 days (14 days of 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 posted10 Nov 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Hepatic FunctionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398424
- Sponsor's protocol ID
- TPU-S1112
- Status last verified
- Aug 2024
- First submitted
- 8 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 I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT00398424
- Acronym / sponsor ID
- TPU-S1112
- Conditions
- Impaired Hepatic Function
- Keywords
- Impaired Hepatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 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 I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe.
Six patients will be enrolled inot each cohort and receive S-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 (23 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:
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- 4. Has known sensitivity to 5-FU. 5. Is a pregnant or lactating female. 6. Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients).
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-1/CisplatinPK Phase (Part 1), Beginning on Day 1 of the Pharmacokinetic Phase, 30 mg/m2 S-1 will be administered orally BID for 14 days (Days 1 through 14), followed by a 1-week recovery period. On Day -2 and Day 14 of the Pharmacokinetic Phase, all patients will receive a single dose of 30 mg/m2 S-1 administered orally. Extension Phase, Patients will receive S-1 at the dose that they tolerated in the PK Phase. S-1 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 | – |
Primary outcome
To provide specific dosing recommendations for S-1 in patients with hepatic impairment based on the PK of S-1 and its components after single dose and during steady state condition
Time frame: The Pharmacokinetic Phase (Part 1) of the study will last 24 days.
1 secondary outcome
To assess the antitumor activity and safety profile of S-1 in patients with impaired hepatic function
Time frame: Each cycle of the Extension Phase (Part 2) will be 21 days (14 days of 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.
6 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/Cisplatin in people with Impaired Hepatic Function, run by Taiho Oncology, Inc. at 6 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 12 inclusion and 23 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 6 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?
To provide specific dosing recommendations for S-1 in patients with hepatic impairment based on the PK of S-1 and its components after single dose and during steady state condition (time frame: The Pharmacokinetic Phase (Part 1) of the study will last 24 days.). 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.