A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

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NCT00769067

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Study Location
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
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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 Cancer
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 measurable Non-Small Cell Lung Cancer (NSCLC);

- progressed after 1-2 prior chemotherapy;

- Eastern Cooperative Oncology Group (ECOG) 0-2;

- tissue available for future KRAS/ EGFR testing

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


- prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;


- active or untreated Central Nervous System (CNS) metastases;

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Official Title  ICMJE A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
Brief Summary This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Erlotinib
    Continuous oral dosing at 150 mg daily.
  • Drug: PF-00299804
    Continuous oral dosing at 45mg daily
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Erlotinib
  • Experimental: B
    Intervention: Drug: PF-00299804
Publications * Ramalingam SS, O'Byrne K, Boyer M, Mok T, Jänne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum in: Ann Oncol. 2016 Jul;27(7):1363.

*   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: November 18, 2011)		188
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2008)		160
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  • progressed after 1-2 prior chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) 0-2;
  • tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

  • prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  • active or untreated Central Nervous System (CNS) metastases;
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 Australia,   Brazil,   Canada,   Hong Kong,   Korea, Republic of,   Poland,   Puerto Rico,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00769067
Other Study ID Numbers  ICMJE A7471028
2008-005235-14 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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 September 2015

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