41
Participants
Start Date
January 31, 2012
Primary Completion Date
July 31, 2015
Study Completion Date
July 31, 2015
E7449 alone
Will be administered as single agent orally, once daily (QD) continuously in 28-day cycles to determine the MTD. In these subjects, a food-effect component will be conducted under fed/fasted conditions to determine the effect of food on the bioavailability of E7449 administered orally QD.
E7449 plus TMZ
Dose escalation,will be administered orally, once daily for 7 consecutive days along with 150 mg/m2/d TMZ administered orally, once daily for 5 consecutive days in 28-day cycles to determine the MTD of E7449 in combination with TMZ.
E7449 plus carboplatin and paclitaxel
Dose escalation, E7449 will be administered orally, once daily continuously in 21-day cycles along with carboplatin and paclitaxel, which will be administered via i.v. infusion on Day 1 of the cycle only, to determine the MTD of E7449 in combination with carboplatin and paclitaxel.
King's College London Guy's Hospital Campus, London
Newcastle Upon Tyne NHS Foundation Trust, Newcastle Upon Tyne and Wear
Eisai Limited
INDUSTRY