CompletedPhase 2NCT00932451
Official study title

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

Study summary

This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-02341066

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 13, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?280 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: PF-02341066
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  • may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  • Tumors can be measurable or non measurable
Reasons someone may not be able to joinExclusion criteria
  • prior treatment with PF-02341066
  • received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  • current enrollment in another therapeutic clinical trial

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • University of Alabama at BirminghamBirmingham, Alabama
  • University of Arkansas for Medical SciencesLittle Rock, Arkansas
  • Comprehensive Blood and Cancer CenterBakersfield, California
  • Tower Cancer Research FoundationBeverly Hills, California
  • Tower Hematology Oncology Medical GroupBeverly Hills, California
  • Moores UCSD Cancer CenterLa Jolla, California
  • UCSD Medical Center - La JollaLa Jolla, California
  • Drug Shipping Address: Ronald Reagen University of California-Los AngelesLos Angeles, California
  • Ronald Reagen University of California-Los Angeles Medical CenterLos Angeles, California
  • UCLA Opthalmic Oncology CenterLos Angeles, California
  • University of California-Los AngelesLos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 13, 2017. Always confirm current availability with the study team.

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