BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
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.