54
Participants
Start Date
May 31, 2013
Primary Completion Date
September 30, 2016
Study Completion Date
September 30, 2016
LAM561
"Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of LAM561 may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances."
Vall D'Hebron Institute of Oncology, Barcelona
Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre, Bilbao
Onkologikoa, San Sebastián
Sir Bobby Robson Cancer Trials Research Centre, The Northern Centre for Cancer Care, Freeman Hospital, Newcastle
The Royal Marsden Hospital Drug Development Unit, Sutton
Lead Sponsor
Specialized Medical Services (SMS)-Oncology BV
UNKNOWN
Royal Marsden NHS Foundation Trust
OTHER
Northern Institute for Cancer Research, Newcastle
UNKNOWN
Vall d'Hebron Institute of Oncology
OTHER
Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre. Bilbao
UNKNOWN
Onkologikoa, San Sebastián.
UNKNOWN
Laminar Pharmaceuticals
INDUSTRY