Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

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NCT00553254

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Study Location
Seoul National University Hospital, Department of Internal Medicine
Seoul, , 110-744, Korea, Republic of
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Contact
1-800-718-1021
[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 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Advanced NSCLC

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

- Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment

- Measurable disease

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


- Patients with known brain Metastases


- Patients with demonstrated history of or presence of interstitial lung disease.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
Official Title  ICMJE A PHASE 1/2, OPEN-LABEL, SINGLE ARM TRIAL TO DETERMINE THE RECOMMENDED PHASE 2 DOSE AND EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS IN KOREA WITH KRAS WILD TYPE ADVANCED NSCLC, WHICH IS REFRACTORY TO CHEMOTHERAPY AND ERLOTINIB OR GEFITINIB
Brief Summary To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.
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
Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PF-00299804
Publications * Park K, Cho BC, Kim DW, Ahn MJ, Lee SY, Gernhardt D, Taylor I, Campbell AK, Zhang H, Giri N, Letrent SP, O'Connell J, Heo DS. Safety and efficacy of dacomitinib in korean patients with KRAS wild-type advanced non-small-cell lung cancer refractory to chemotherapy and erlotinib or gefitinib: a phase I/II trial. J Thorac Oncol. 2014 Oct;9(10):1523-31. doi: 10.1097/JTO.0000000000000275.

*   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: May 12, 2011)		55
Original Enrollment  ICMJE
 (submitted: November 2, 2007)		80
Actual Study Completion Date  ICMJE July 17, 2014
Actual Primary Completion Date August 3, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced NSCLC
  • Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
  • Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
  • Measurable disease

Exclusion Criteria:

  • Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment
  • Patients who lack of tolerance of erlotinib therapy
  • Patients with known brain Metastases
  • Patients with demonstrated history of or presence of interstitial lung disease.
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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00553254
Other Study ID Numbers  ICMJE A7471003
Has Data Monitoring Committee Not Provided
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 September 2020

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