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An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

NCT00932893 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2017-01-02

Study results available
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Summary

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

PF-02341066

PF-02341066, 250 mg BID will be administered orally on a continuous schedule

DRUG

Pemetrexed

Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle

DRUG

Docetaxel

Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-03-31
Completion
2016-01-31

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT00932893 on ClinicalTrials.gov