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PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00548093
First received: October 19, 2007
Last updated: June 4, 2012
Last verified: June 2012
History of Changes

October 19, 2007
June 4, 2012
April 2008
March 2010   (final data collection date for primary outcome measure)
Best Overall response, according to Response Evaluation Criteria in Solid Tumors in Non-Small Cell Lung Cancer (NSCLC), adenocarcinoma histology. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Best Overall response according to Response Evaluation Criteria in Solid Tumors.
Complete list of historical versions of study NCT00548093 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) and OS at 1 year (OS12m). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetics of the study drug [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression -free survival (PFS) and PFS at 6 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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: 6 months ] [ Designated as safety issue: Yes ]
  • Explore patient reported outcomes of health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Exploratory molecular profiling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Best response by Response Evaluation Criterion in Solid Tumors (RECIST) in non-adenocarcinoma arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of overall response. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of overall response.
  • Progression -free survival (PFS) and PFS at 6 months.
  • Overall survival (OS) and OS at 1 year (OS12m).
  • 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
 
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
A Phase 2, Open Label, Two Arm Trial To Evaluate The Efficacy Of PF-00299804 In Patients With Advanced NSCLC After Failure Of At Least One Prior Chemotherapy And Erlotinib

To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non Small Cell Lung
Drug: PF-00299804
PF-00299804 orally at 45 mg daily, on continuous schedule
  • Experimental: 1
    descriptive: adenocarcinoma histology
    Intervention: Drug: PF-00299804
  • Experimental: 2
    descriptive: non-adenocarcinoma histology
    Intervention: Drug: PF-00299804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2012
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced Non-Small Cell Lung Cancer (NSCLC)
  • Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
  • Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
  • Measurable disease .
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Tissue available for KRAS/ EGFR testing
  • Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN

Exclusion Criteria:

  • Chemotherapy
  • Radiotherapy
  • Biological or investigational agents within 4 weeks of baseline disease assessment.
  • Patients who lack of tolerance of erlotinib therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00548093
A7471002
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

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