A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-small Cell
Both
Carcinoma, Non-small Cell
Trial Information
A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung
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
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:
Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort A] PFS is defined as the interval from enrollment to date of objective progression or death due to any cause.
Outcome Time Frame:
10 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A7471017
NCT ID:
NCT00818441
Start Date:
March 2009
Completion Date:
March 2015
Related Keywords:
- Carcinoma, Non-Small Cell
- lung cancer adenocarcinoma HER2
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma
- Lung Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Bismarck, North Dakota 58503 |
