Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 4:58 AM
Study NCT ID:
NCT00651833
Status:
COMPLETED
Last Update Posted:
2024-09-03
First Post:
2008-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer
Sponsor:
Taiho Oncology, Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Non-Randomized, Multicenter, Three-Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether S-1 in combination with Cisplatin is effective as 1st line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.
Detailed Description:
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione \[FT\]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine \[CDHP\]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of S-1 in combination with cisplatin as 1st line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a run-in tolerability stage (stage 1), futility stage (stage 2), and decision stage (stage 3). The run-in tolerability stage will be conducted to assess any additional toxicity associated with a more frequent schedule of administration of cisplatin (75 mg/m2 every 3 weeks) compared with the dosing regimen established in a prior Phase I study in patients with advanced gastric cancer (75 mg/m2 every 4 weeks). The futility stage (stage 2) will be conducted to ensure that this treatment combination is sufficiently efficacious to expose a sufficient number of patients to be able to make a decision (stage 3) on whether this combination treatment warrants further evaluation in future studies.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of S-1 in combination with cisplatin as 1st line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a run-in tolerability stage (stage 1), futility stage (stage 2), and decision stage (stage 3). The run-in tolerability stage will be conducted to assess any additional toxicity associated with a more frequent schedule of administration of cisplatin (75 mg/m2 every 3 weeks) compared with the dosing regimen established in a prior Phase I study in patients with advanced gastric cancer (75 mg/m2 every 4 weeks). The futility stage (stage 2) will be conducted to ensure that this treatment combination is sufficiently efficacious to expose a sufficient number of patients to be able to make a decision (stage 3) on whether this combination treatment warrants further evaluation in future studies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: