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PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

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NCT00548093

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Duarte, California, 91010 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Advanced Non-Small Cell Lung Cancer (NSCLC)

- Prior treatment with and failure of at least one regimen of chemotherapy and
erlotinib.

- Prior treatment with no more than two chemotherapy regimens, including adjuvant or
combined modality treatment.

- Measurable disease .

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- Tissue available for KRAS/ EGFR testing

- Creatinine clearance > 40 cc/min or serum creat

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

- Chemotherapy

- Radiotherapy

- Biological or investigational agents within 4 weeks of baseline disease assessment.

- Patients who lack of tolerance of erlotinib therapy.

NCT00548093
Pfizer
Completed
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

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PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
A Phase 2, Open Label, Two Arm Trial To Evaluate The Efficacy Of PF-00299804 In Patients With Advanced NSCLC After Failure Of At Least One Prior Chemotherapy And Erlotinib
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non Small Cell Lung
Drug: PF-00299804
PF-00299804 orally at 45 mg daily, on continuous schedule
  • Experimental: 1
    descriptive: adenocarcinoma histology
    Intervention: Drug: PF-00299804
  • Experimental: 2
    descriptive: non-adenocarcinoma histology
    Intervention: Drug: PF-00299804
Reckamp KL, Giaccone G, Camidge DR, Gadgeel SM, Khuri FR, Engelman JA, Koczywas M, Rajan A, Campbell AK, Gernhardt D, Ruiz-Garcia A, Letrent S, Liang J, Taylor I, O'Connell JP, Jänne PA. A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer. 2014 Apr 15;120(8):1145-54. doi: 10.1002/cncr.28561. Epub 2014 Feb 5.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2012
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced Non-Small Cell Lung Cancer (NSCLC)
  • Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
  • Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
  • Measurable disease .
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Tissue available for KRAS/ EGFR testing
  • Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN

Exclusion Criteria:

  • Chemotherapy
  • Radiotherapy
  • Biological or investigational agents within 4 weeks of baseline disease assessment.
  • Patients who lack of tolerance of erlotinib therapy.
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
 
 
NCT00548093
A7471002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

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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