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Study of Sorafenib Maintenance in Patients With ED-SCLC After Response to Induction Chemotherapy

NCT01159327 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-11-11

No results posted yet for this study

Summary

A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed Small cell lung cancer (SCLC) has been commenced. In the present randomized phase 2 study, the investigators will research whether Sorafenib maintenance prolongs progression free survival (PFS) and overall survival (OS) in patients with ED-SCLC who achieved CR or PR after platinum-based induction chemotherapy.

Conditions

Interventions

DRUG

Sorafenib

Sorafenib 400mg, bid(800mg/day), daily, PO

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • JI-YOUN HAN, PhD.MD · National Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01159327 on ClinicalTrials.gov