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

Back to Search
Print
Bookmark Trial

NCT00553254

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seoul, , 110-744, Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Non Small Cell Lung CarcinomaTrial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
NCT00553254
  1. Seoul,
  2. Seoul,
  3. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non Small Cell Lung CarcinomaPF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
NCT00548093
  1. Duarte, California
  2. Pasadena, California
  3. South Pasadena, California
  4. Aurora, Colorado
  5. Aurora, Colorado
  6. Aurora, Colorado
  7. Aurora, Colorado
  8. Atlanta, Georgia
  9. Atlanta, Georgia
  10. Atlanta, Georgia
  11. Atlanta, Georgia
  12. Atlanta, Georgia
  13. Bethesda, Maryland
  14. Boston, Massachusetts
  15. Boston, Massachusetts
  16. Boston, Massachusetts
  17. Boston, Massachusetts
  18. Detroit, Michigan
  19. Farmington Hills, Michigan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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 2014
Actual Primary Completion Date August 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 No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 August 2014

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