Clinical Trial Details
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NCT01792310 : A Phase 1/2A Study of Minerval in Adult Patients With Advanced Solid Tumours
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
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

- 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
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