10
Participants
Start Date
November 30, 2012
Primary Completion Date
October 16, 2017
Study Completion Date
October 16, 2017
Afatinib, Ribavirin, and weekly carboplatin/paclitaxel
Patients will receive oral daily afatinib (days 1 - 21, per dose escalation scheme) plus daily oral ribavirin (days 1- 21) and paclitaxel (80 mg/m2 intravenously, days 1 and 8) + carboplatin (AUC 1.5 intravenously, days 1 and 8) of a 21-day cycle. Ribavirin will be administered according to standard weight-based dosing for this drug (1). Subjects ≤75 kg receive Ribavirin 400 mg PO qAM and 600 mg PO qPM (= 1000 mg/day). Subjects \> 75 kg receive Ribavirin 600 mg PO BID (=1200 mg/day). During the Dose Escalation portion of the study (Part 1), research bloodwork for pharmacokinetics is performed on days 1 and 8 of Cycle 1 only.
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge
Collaborators (1)
National Comprehensive Cancer Network
NETWORK
Boehringer Ingelheim
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER