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Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer

NCT00651833 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

S-1

All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • United BioSource, LLC

    collaborator INDUSTRY

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Fabio Benedetti, MD · Taiho Oncology, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-10-31
Completion
2007-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651833 on ClinicalTrials.gov