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

Inclusion Criteria

* Males or females providing written, informed consent
* Histologically- or cytologically-confirmed advanced solid malignancy that is refractory to standard-of-care treatment, or for which there is no standard therapy. If this is glioma:Grade III / Grade IV malignant glioma recurring or progressing after first or second line standard-of-care treatment and true progressive disease, confirmed according to the RANO criteria 4.
* Life-expectancy of at least 12 weeks
* Eastern cooperative oncology group (ECOG) performance status of 0-2
* Safety laboratory tests and ECGs within specified limits.
* Using adequate contraception, where applicable
* Presence of lesions suitable for biopsy (mandatory for non-glioma patients enrolled in the expanded safety cohort and highly desirable for non-glioma patients enrolled in the dose escalation phase)

Exclusion Criteria

* Anti cancer therapy within 4 weeks (6 weeks for mitomycin and nitrosureas and 2 weeks for palliative radiotherapy)
* NCI Common terminology criteria for adverse events (CTCAE) \>Grade 1 toxicities from prior chemotherapy or radiotherapy that could impact on safety outcome assessment
* Recent \>Grade 1 intracranial or intratumoural haemorrhage either by CT or MRI scan. Patients with resolving haemorrhage changes, punctuate haemorrhage or haemosiderin may enter the study
* Significant or uncontrolled cardiovascular disease, unstable angina or myocardial infarction within the preceding 6 months
* Known impairment of GI function that could alter the absorption of study drug
* History of uncontrolled hyperlipidemia and/or the need for concurrent lipid lowering therapy
* Concurrent severe and/or uncontrolled other medical disease that could compromise participation in the study
* Taking warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide, glyburide or nateglanide)
* Pregnant or breast feeding Other protocol specific criteria may apply