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Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer

NCT00651742 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.

Conditions

  • Locally Advanced or Metastatic Pancreatic Cancer

Interventions

DRUG

S-1

All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • United BioSource, LLC

    collaborator INDUSTRY

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Taiho Central · 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
2006-01-09
Primary Completion
2008-07-08
Completion
2008-07-08
FDA Drug
Yes

More Related Trials

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 NCT00651742 on ClinicalTrials.gov