BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours

NCT01169675 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-06-09

Study results available

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.

Conditions

Neoplasms

Interventions

DRUG

BIBW 2992 low dose

patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle

DRUG

BIBW 2992 high dose

patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle

DRUG

pemetrexed