Neoplasms Clinical Trial
Official title:
BIBW 2992 Phase I Combination With Pemetrexed in Advanced Solid Tumours
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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