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

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Study Location
City of Hope
Duarte, California, 91010, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

By email

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[email protected]

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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
18-99 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 < 1.5 x ULN

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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
Official Title  ICMJE 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 REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non Small Cell Lung
Intervention  ICMJE Drug: PF-00299804
PF-00299804 orally at 45 mg daily, on continuous schedule
Study Arms  ICMJE
  • Experimental: 1
    descriptive: adenocarcinoma histology
    Intervention: Drug: PF-00299804
  • Experimental: 2
    descriptive: non-adenocarcinoma histology
    Intervention: Drug: PF-00299804
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2012)		66
Original Enrollment  ICMJE
 (submitted: October 19, 2007)		80
Actual Study Completion Date  ICMJE June 11, 2012
Actual Primary Completion Date March 16, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00548093
Other Study ID Numbers  ICMJE A7471002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 May 2019

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