Gastric CancerPhase 2NCT00197431
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
A Phase 2 study testing S-1 in people with Gastric Cancer and Esophageal Cancer, run by Hamamatsu University at 1 site in Japan.
Trial summary
S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer, Pancreatic Cancer
- What is being tested?
- S-1
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Jan 2004to not given
- Phase
- Phase 2
- 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 20 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with digestive organ cancer
Who cannot join
- Patients without digestive organ cancer
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192
Naohito Shirai, MD., PhD, 81-534-2870, naohito@hama-med.ac.jp
Takahisa Furuta, MD., PhD
About this study
Official title: Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD
S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.
- Conditions
- Gastric Cancer, Esophageal Cancer, Pancreatic Cancer, Colon Cancer
- Being tested
- S-1
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
Secondary outcomes (1)
Side effect and motility of patients treated with S-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Investigators
- Naohito Shirai, MD., PhD, Study chair, Department Laboratory Medicine, Hamamatsu University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197431
- Sponsor's protocol ID
- S-12005
- Status last verified
- Dec 2003
- First submitted
- 12 Sep 2005
- Last updated
- 22 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD
- ClinicalTrials.gov ID
- NCT00197431
- Acronym / sponsor ID
- S-12005
- Conditions
- Gastric Cancer, Esophageal Cancer, Pancreatic Cancer, Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Jan 2004
- First posted
- 20 Sep 2005 (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.
S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with digestive organ cancer
Key exclusion criteria (1 listed)
- Patients without digestive organ cancer
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 | Drug | – |
Primary outcome
Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
1 secondary outcome
Side effect and motility of patients treated with S-1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2006.
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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.
Naohito Shirai, MD., PhD study chair
Department Laboratory Medicine, Hamamatsu University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 in people with Gastric Cancer and Esophageal Cancer, run by Hamamatsu University at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2006. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naohito Shirai, MD., PhD (81-534-2788, naohito@hama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes. 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 22 Mar 2006.