A Phase 1/2A Study of LAM561 in Adult Patients With Advanced Solid Tumours

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
GliomaOther Solid Tumours
Interventions
DRUG

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."

Trial Locations (5)

Unknown

Vall D'Hebron Institute of Oncology, Barcelona

Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre, Bilbao

Onkologikoa, San Sebastián

NE7 7DN

Sir Bobby Robson Cancer Trials Research Centre, The Northern Centre for Cancer Care, Freeman Hospital, Newcastle

SM25PT

The Royal Marsden Hospital Drug Development Unit, Sutton

Sponsors
All Listed Sponsors
collaborator

Specialized Medical Services (SMS)-Oncology BV

UNKNOWN

collaborator

Royal Marsden NHS Foundation Trust

OTHER

collaborator

Northern Institute for Cancer Research, Newcastle

UNKNOWN

collaborator

Vall d'Hebron Institute of Oncology

OTHER

collaborator

Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre. Bilbao

UNKNOWN

collaborator

Onkologikoa, San Sebastián.

UNKNOWN

lead

Laminar Pharmaceuticals

INDUSTRY

NCT01792310 - A Phase 1/2A Study of LAM561 in Adult Patients With Advanced Solid Tumours | Biotech Hunter | Biotech Hunter