At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Open Label Trial of Continuous Once Daily Oral Treatment With BIBW 2992 - Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib.
In Brief
A Phase 2 clinical trial evaluating BIBW 2992 MA2 40mg/day, BIBW 2992 MA2 50mg/day, and 2 other interventions for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 74 participants across 20 sites.
Detailed Summary
The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine the recommended dose for the Phase II step. The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose determined in the Phase I step.
Study Details
Timeline
Interventions
Phase I step: Increased dose cohorts from low dose to MTD
Phase I step: Increased dose cohorts from low dose to MTD
Phase I step: Increased dose cohorts from low dose to MTD
Phase II step: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs.