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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00553254
First received: November 2, 2007
Last updated: August 6, 2014
Last verified: August 2014

November 2, 2007
August 6, 2014
February 2008
August 2010   (Final data collection date for primary outcome measure)
  • Endpoints- Phase 1- Recommended phase 2 dose. [ Time Frame: 30-AUG-2008 ]
  • Phase 2- Progression -free survival at 4 months [ Time Frame: 26-JUL-2010 ]
  • Phase 2- Overall response according to Response Evaluation Criteria in Solid Tumors.
  • Endpoints- Phase 1- Recommended phase 2 dose.
Complete list of historical versions of study NCT00553254 on ClinicalTrials.gov Archive Site
  • Overall response according to Response Evaluation Criteria in Solid Tumors. [ Time Frame: 30-JAN-2010 ]
  • Overall survival at 6 months [ Time Frame: 26-JUL-2010 ]
  • Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed. [ Time Frame: 26-JUL-2010 ]
  • Phase 1- Single and multiple dose pharmacokinetic parameters of PF_00299804 [ Time Frame: 30-MAR-2009 ]
  • Phase 2-Duration of overall response [ Time Frame: 26-JUL-2010 ]
  • Phase 1-
  • 1. Single and multiple dose pharmacokinetic parameters of PF_00299804
  • Phase 2-
  • 1. Duration of overall response
  • 2. Progression -free survival at 6 months
  • 3. Overall survival at 6 months
  • 4. Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed.
Not Provided
Not Provided
 
Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
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
To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non Small Cell Lung
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
Experimental: 1
Intervention: Drug: PF-00299804
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.
 
Completed
55
July 2014
August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00553254
A7471003
No
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

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