Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced NSCLC
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
Trial Information
Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced NSCLC
Inclusion Criteria:
- Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV).
- Evidence of T790M mutation to enroll in Cohort A.
- Evidence of measurable disease by radiographic technique.
- Adequate organ function.
Exclusion Criteria:
- Patients with T790M mutation who stopped any prior EGFR-directed therapy without
evidence of disease progression.
- Symptomatic brain metastases.
- Uncontrolled or significant cardiovascular disease.
- Pregnant or breastfeeding.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best Overall Response
Outcome Time Frame:
Baseline up to 78 weeks
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:
A7471047
NCT ID:
NCT01858389
Start Date:
July 2013
Completion Date:
September 2015
Related Keywords:
- Non-Small Cell Lung Cancer
- Non-small cell lung cancer
- T790M mutation. dacomitinib
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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