Renal ImpairmentPhase 1NCT00398307
Evaluating Patients With Varying Degrees of Renal Function
A Phase 1 study testing S-1/Cisplatin in people with Renal Impairment, run by Taiho Oncology, Inc. at 9 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 renal function. Patients will be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal clearance formula: Group A: Control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Impairment
- What is being tested?
- S-1/Cisplatin
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2006to Sep 2010
- 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).
Show all 37Show fewer
- Has adequate organ function as defined by the following criteria:
- 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.
- Total serum bilirubin ≤ 1.5 times ULN.
- 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.
- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- 3.3.2 Exclusion Criteria
- 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.
- 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, Appendix E, 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.
- Known brain metastasis.
- Known leptomeningeal metastases.
- Requires hemodialysis.
- 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.
- 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:
- 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).
- Has known 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
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cancer Research & Treatment Center/University of New Mexico
Albuquerque, New Mexico, 87131
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation
Lexington, Kentucky, 40536
LAC/USC Medical Center
Los Angeles, California, 90033
Yale Cancer Center
New Haven, Connecticut, 06520
The Institute for Drug Development
San Antonio, Texas, 78245
Premiere Oncology
Santa Monica, California, 90404
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 in Patients With Varying Degrees of Renal 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 renal function. Patients will be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal clearance formula:
Group A: Control Group B:Mild renal dysfunction Group C:Moderate renal function and Group D: Severe renal dysfunction. Six patients will be enrolled into each cohort.
- Conditions
- Renal Impairment
- Being tested
- S-1/Cisplatin
- Keywords
- Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1/CisplatinDrug
S-1 administration will be determined by degree of renal impairment as follows:
Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD
Pharmacokinetic Phase (Part 1):
On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning.
Treatment will be followed by 1 week of recovery (Days 15 through 21).
Extension Phase (Part 2):
S-1 will be administered orally 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 renal impairment based on the PK of S-1 and its components after single dose and steady state conditions.
Measured: The Pharmacokinetic Phase (Part 1) of the study will last 24 days.
Secondary outcomes (1)
Assess Anti-tumor activity, and safety profile of S-1 in patients with impaired renal 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 completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398307
- Sponsor's protocol ID
- TPU-S1111
- Status last verified
- Aug 2024
- First submitted
- 8 Nov 2006
- Last updated
- 5 Sep 2024
- Results posted
- 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 I, Open-Label Study Evaluating the Pharmacokinetics of Components of S-1 in Patients With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT00398307
- Acronym / sponsor ID
- TPU-S1111
- Conditions
- Renal Impairment
- Keywords
- Renal Impairment
- 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
- Sep 2010 (actual)
- Study completion
- Sep 2010 (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 renal function. Patients will be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal clearance formula:
Group A: Control Group B:Mild renal dysfunction Group C:Moderate renal function and Group D: Severe renal dysfunction. Six patients will be enrolled into each cohort.
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 (37 listed)
- A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- 3.3.2 Exclusion Criteria
- 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:
Key exclusion criteria (0 listed)
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/CisplatinS-1 administration will be determined by degree of renal impairment as follows: Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD Pharmacokinetic Phase (Part 1): On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning. Treatment will be followed by 1 week of recovery (Days 15 through 21). Extension Phase (Part 2): S-1 will be administered orally 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 renal impairment based on the PK of S-1 and its components after single dose and steady state conditions.
Time frame: The Pharmacokinetic Phase (Part 1) of the study will last 24 days.
1 secondary outcome
Assess Anti-tumor activity, and safety profile of S-1 in patients with impaired renal 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 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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Renal Impairment, run by Taiho Oncology, Inc. at 9 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 37 inclusion and 0 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 9 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 renal impairment based on the PK of S-1 and its components after single dose and steady state conditions. (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 5 Sep 2024.