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
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non Small Cell Lung
Both
Carcinoma, Non Small Cell Lung
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Endpoints- Phase 1- Recommended phase 2 dose.
Outcome Time Frame:
30-AUG-2008
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A7471003
NCT ID:
NCT00553254
Start Date:
February 2008
Completion Date:
December 2013
Related Keywords:
- Carcinoma, Non Small Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
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