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

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NCT00932893

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Study Location
University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute
Little Rock, Arkansas, 72205, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- histologically or cytologically proven diagnosis of non-small cell lung cancer

- positive for the ALK fusion gene (test provided by a central laboratory)

- must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug

- tumors must be measurable

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- prior treatment with PF-02341066


- current treatment in another clinical trial

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: PF-02341066
    Intervention: Drug: PF-02341066
  • Active Comparator: Pemetrexed or Docetaxel
    Investigator selection of either pemetrexed or docetaxel as the active comparator
    Interventions:
    • Drug: Pemetrexed
    • Drug: Docetaxel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)		347
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2009)		318
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by a central laboratory)
  • must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  • tumors must be measurable

Exclusion Criteria:

  • prior treatment with PF-02341066
  • current treatment in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Bulgaria,   Canada,   China,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00932893
Other Study ID Numbers  ICMJE A8081007
2009-012595-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP