Status:
COMPLETED
A Phase 1/2A Study of LAM561 in Adult Patients With Advanced Solid Tumours
Lead Sponsor:
Laminar Pharmaceuticals
Collaborating Sponsors:
Specialized Medical Services (SMS)-Oncology BV
Royal Marsden NHS Foundation Trust
Conditions:
Glioma
Other Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1/2A, open label, non-randomized study in patients with advanced solid tumours including malignant glioma
Detailed Description
This is an open label, non-randomized study in patients with advanced solid tumours including malignant glioma. The study will be performed in two phases - a dose escalation phase following a standard...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01792310
Start Date
May 1 2013
End Date
September 1 2016
Last Update
February 21 2023
Active Locations (5)
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1
Vall D'Hebron Institute of Oncology
Barcelona, Spain
2
Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre
Bilbao, Spain
3
Onkologikoa
San Sebastián, Spain
4
Sir Bobby Robson Cancer Trials Research Centre, The Northern Centre for Cancer Care, Freeman Hospital
Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN