At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BIBW 2992 Phase I Combination With Pemetrexed in Advanced Solid Tumours
In Brief
A Phase 1 clinical trial evaluating BIBW 2992 low dose, BIBW 2992 high dose, and 5 other interventions for Neoplasms. Completed, enrolled 53 participants across 2 sites.
Detailed Summary
This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle. The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.
Study Details
Timeline
Interventions
patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle
patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle
given intravenously on day 1 of a 21 day cycle
given intravenously on day 1 of a 21 day cycle
patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle
given intravenously on day 1 of a 21 day cycle
given intravenously on day 1 of a 21 day cycle
given intravenously on day 1 of a 21 day cycle
given intravenously on day 1 of a 21 day cycle
patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle
patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle
patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle