Pharmacokinetic and Pharmacodynamic Study of S-1 in Patie... | NCT00197431

Studies
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

NCT00197431

Sponsor

Hamamatsu University

Status

Unknown status

Last Update Posted

Mar 22, 2006Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Gastric Cancer
Esophageal Cancer
Pancreatic Cancer
Colon Cancer

Interventions

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2006

Last Update Posted Date

Mar 22, 2006Estimated

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
S-1	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes

Secondary Outcomes

Measure	Description	Time Frame
Side effect and motility of patients treated with S-1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with digestive organ cancer

Exclusion Criteria:

Patients without digestive organ cancer

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naohito Shirai, MD., PhD	Contact	81-534-2788		naohito@hama-med.ac.jp

Overall Officials

Name	Affiliation	Role
Naohito Shirai, MD., PhD	Department Laboratory Medicine, Hamamatsu University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamamatsu University School of Medicine	Recruiting	Hamamatsu	Shizuoka	431-3192	Japan

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D004938	Esophageal Neoplasms
D010190	Pancreatic Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C079198	S 1 (combination)

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided