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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
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

NCT00932893
Pfizer
Completed
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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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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
347
January 2016
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Argentina
 
NCT00932893
A8081007
2009-012595-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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