Status:
COMPLETED
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
Lead Sponsor:
Pfizer
Conditions:
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact ...
Eligibility Criteria
Inclusion
- Advanced Non-Small Cell Lung Cancer (NSCLC).
- For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
- For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed\>12 months prior to enrollment.
- All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Estimated creatinine clearance ≥15 mL/min.
Exclusion
- Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
- Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
- Patients with known diffuse interstitial lung disease (all cohorts).
- Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)
Key Trial Info
Start Date :
December 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2015
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01465802
Start Date
December 26 2011
End Date
May 18 2015
Last Update
January 9 2019
Active Locations (81)
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1
City of Hope
Duarte, California, United States, 91010
2
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
3
UCLA Hematology Oncology
Irvine, California, United States, 92604
4
UC San Diego Medical Center - La Jolla
La Jolla, California, United States, 92037