Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

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NCT00818441

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Study Location
University of California, Irvine
Orange, California, 92868-3298, 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 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 adenocarcinoma of lung, measurable disease

- Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR

- patients with known EGFR activating mutation regardless of smoking status

- ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

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


- Active brain metastases


- Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had
any number of prior lines of systemic therapy.


- known EGFR wild type NSCLC

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Non-small Cell CarcinomaDacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
NCT00818441
  1. Orange, California
  2. Orange, California
  3. Pleasant Hill, California
  4. Salinas, California
  5. San Francisco, California
  6. Aurora, Colorado
  7. Aurora, Colorado
  8. Fort Myers, Florida
  9. Bethesda, Maryland
  10. Boston, Massachusetts
  11. Boston, Massachusetts
  12. Boston, Massachusetts
  13. Boston, Massachusetts
  14. Boston, Massachusetts
  15. Boston, Massachusetts
  16. Boston, Massachusetts
  17. Springfield, Missouri
  18. New York, New York
  19. Stony Brook, New York
  20. Chapel Hill, North Carolina
  21. Chapel Hill, North Carolina
  22. Chapel Hill, North Carolina
  23. Durham, North Carolina
  24. Bismarck, North Dakota
  25. Bismarck, North Dakota
  26. Chattanooga, Tennessee
  27. Nashville, Tennessee
  28. Nashville, Tennessee
  29. Richmond, Virginia
  30. Seattle, Washington
  31. Seattle, Washington
  32. Tuen Mun, NEW Territories
  33. Tuen Mun, NEW Territories
  34. New Territories,
  35. Shatin, NT,
  36. Koto-Ku, Tokyo
  37. Aichi,
  38. Seoul,
  39. Seoul,
  40. Seoul,
  41. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
Official Title  ICMJE A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
Brief Summary This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
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
Intervention  ICMJE
  • Drug: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
  • Drug: Dacomitinib (PF-00299804)
    In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.
Study Arms  ICMJE
  • Experimental: Cohort A
    Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
    Intervention: Drug: Dacomitinib (PF-00299804)
  • Experimental: Cohort B
    Dacomitinib in patients with HER2 mutated or amplified NSCLC
    Intervention: Drug: Dacomitinib (PF-00299804)
Publications *

*   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: April 25, 2016)		119
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)		80
Actual Study Completion Date  ICMJE April 30, 2015
Actual Primary Completion Date April 27, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced adenocarcinoma of lung, measurable disease
  • Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  • patients with known EGFR activating mutation regardless of smoking status
  • ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion Criteria:

  • Active brain metastases
  • Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  • known EGFR wild type NSCLC
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 Hong Kong,   Japan,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818441
Other Study ID Numbers  ICMJE A7471017
2011-002794-39 ( EudraCT Number )
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 December 2018

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