24
Participants
Start Date
December 31, 2004
Primary Completion Date
November 30, 2007
Study Completion Date
November 30, 2007
lapatinib ditosylate
"For patients receiving enzyme inducing anti-epileptic drugs (EIAEDs):~* Phase I: starting dose for first cohort: 1000 mg GW572016 po b.i.d.; actual dose assigned at registration; intra patient dose escalation permitted ONCE in phase I patients ONLY if specified criteria met (see section 8.6).~* Phase II: Recommended phase II dose from phase I portion of the study, given po b.i.d.~For patients NOT receiving enzyme inducing anti-epileptic drugs (NON-EIAEDs):~• Phase II: 750 mg GW572016 po b.i.d.~For all patients:~• Dose reductions as required based on adverse events."
Tom Baker Cancer Centre - Calgary, Calgary
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna
British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver
Margaret and Charles Juravinski Cancer Centre, Hamilton
Princess Margaret Hospital, Toronto
Centre Hospitalier de l'Universite de Montreal, Montreal
Collaborators (1)
NCIC Clinical Trials Group
NETWORK
National Cancer Institute (NCI)
NIH