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Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 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 Cancer
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 proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally
advanced or metastatic and of the adenocarcinoma subtype (including mixed
adenosquamous histology)

- evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST)
after at least one but no more than 2 chemotherapy regimens for advanced disease

- tumors must have measurable disease as per RECIST

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

- known interstitial lung disease

- prior treatment with an agent that is known or proposed to be active by action on EGFR
tyrosine kinase or c-Met/HGF (Phase 2 Portion)

NCT00965731
Pfizer
Completed
Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

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Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung.
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Erlotinib
    Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
  • Drug: Erlotinib
    For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2
  • Drug: PF-02341066
    For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
  • Active Comparator: Erlotinib
    Intervention: Drug: Erlotinib
  • Experimental: Erlotinib + PF-02341066
    Interventions:
    • Drug: Erlotinib
    • Drug: PF-02341066
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
January 2014
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
  • evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
  • tumors must have measurable disease as per RECIST

Exclusion Criteria:

  • known interstitial lung disease
  • prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00965731
A8081002
2009-012377-35 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

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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[email protected]



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