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Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

NCT00652561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-09-03

No results posted yet for this study

Summary

The purpose of this study is to determine whether S-1 is effective as 2nd 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 30 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 second stage only if the stage 2 criteria are met, where 3/30 (10%) or more patients must have achieved a confirmed response (CR or PR) in stage 1.The study may go to the third stage only if at least 8/50 patients (16%) must have achieved a confirmed response in stage 2

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
2007-11-30
Completion
2007-11-30

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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 NCT00652561 on ClinicalTrials.gov