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A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

NCT01904253 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-09-05

No results posted yet for this study

Summary

The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.

Conditions

  • Small Cell Lung Cancer (SCLC)

Interventions

DRUG

TAS-102

35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

DRUG

Amrubicin (Japan)

Patients will receive treatment administered according to the country-specific approved prescribing information

DRUG

Topotecan (Japan/Europe)

Patients will receive treatment administered according to the country-specific approved prescribing information

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Giorgio Scagliotti, MD · University of Turin San Luigi Hospital

  • Kaoru Kubota, MD, PhD · Nippon Medical School Hospital Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Germany
  • Italy
  • Japan

Study Locations

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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 NCT01904253 on ClinicalTrials.gov