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PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer

NCT01000025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2023-08-22

Study results available
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Summary

RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer.

Conditions

Interventions

DRUG

PF-00299804

PF-804 45 mg PO, daily

DRUG

Placebo

Placebo 45 mg PO, daily

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Peter Ellis, MD · Margaret and Charles Juravinski Cancer Centre

  • Penny Bradbury, MD · NCIC Clinical Trials Group

  • Michael Millward, MD · Sir Charles Gairdner Hospital - Nedlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-23
Primary Completion
2014-01-15
Completion
2015-11-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Italy
  • New Zealand
  • Peru
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

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 NCT01000025 on ClinicalTrials.gov