drugset / Trial / NCT01465802

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

NCT01465802

Phase 2 Completed 236 enrolled Pfizer
Non-randomizedOpen-labelTreatment

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 of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).

Timeline

Start
2011-12-26
Primary completion
2015-05-18
Completion
2015-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Alclometasone Unknown 0.05 % Topical
Subject DACOMITINIB ANHYDROUS Small molecule 45 mg Oral
Subject Doxycycline Small molecule 100 mg Oral
Subject VSL#3 Other / unclassified Oral