Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Taiho Pharma USA, Inc. |
---|---|
Information provided by: | Taiho Pharma USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00400023 |
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).
Condition | Intervention | Phase |
---|---|---|
Tumors |
Drug: S-1 Drug: FT |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 12 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive one of the following treatment sequences:
|
Drug: S-1
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. |
2: Active Comparator
During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive one of the following treatment sequences:
|
Drug: FT
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
Has adequate organ function as defined by the following criteria:
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:
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:
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:
United States, Arizona | |
Premiere Oncology of Arizona | |
Scottsdale, Arizona, United States, 85260 | |
United States, California | |
Premiere Oncology, A Medical Corporation | |
Santa Monica, California, United States, 90404 | |
United States, Connecticut | |
Yale Cancer Center | |
New Haven, Connecticut, United States, 06520 |
Responsible Party: | Taiho Pharma USA, Inc. ( Peter Urrea/Senior VP Clinical and Regulatory Affairs ) |
Study ID Numbers: | TPU-S1108 |
Study First Received: | November 14, 2006 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00400023 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Solid Tumors |
Dihydrouracil Dehydrogenase (NADP) Dihydropyrimidine Dehydrogenase Deficiency |