Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Evidence of cancer, by histopathology or cytology, which was not amenable to any standard therapy or was refractory to conventional therapy
Age ≥ 18 years
Life expectancy of at least 12 weeks
WHO performance status of 0-2

Hematological and biochemical indices at the start of treatment:

Hemoglobin at least 9 g/dl
Leukocyte count at least 3.0 x 109/l
Neutrophils at least 1.5 x 109/l
Platelets at least 100 x 109/l
Serum Creatinine not higher than140 μmol/l
Liver function tests (ALT, AST, ALK PHOS) no higher than thrice the upper limit of the reference range, if no demonstrable liver metastases or no more than 5 x upper limit of the normal range in the presence of liver or bone metastases
Absolute QTc interval values of less than 470 ms in females and less than 450 ms in males as assessed by the Investigator
Presence of a lesion which was amenable to dynamic MRI
Written informed consent and the ability of the patient to co-operate with treatment and follow up

Exclusion Criteria:

Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks prior to treatment
Pregnant or lactating women were excluded
Patients who were poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection
Current malignancies at other sites
Significant history of recreational drug abuse
Glucocorticosteroids in doses exceeding those required for physiological replacement within the previous 2 weeks
Skin lesions that may prevent long-term ECG acquisition
Body mass index above 30 kg/m2
Patients who were taking certain medications
Patients with clinical evidence of brain metastases

Patients with certain cardiac conditions

Advancing or unstable ischemic heart disease
Pacing devices and/or implantable cardiovertor-defibrillator
Significant cardiovascular disease or any unstable cardiovascular disease
Non-sustained or sustained atrial and/or ventricular tachyarrhythmias
Atrial fibrillation (including paroxysmal atrial fibrillation) or atrial flutter
Bundle Branch Block, any stable intra-cardiac conduction abnormality with QRS complex > 120 ms, any unstable intra-cardiac conduction abnormality
Sick sinus syndrome, or sinus pauses > 2 seconds
Known atrial and/or ventricular ectopic beats > 10/hour
Fixed second degree AV block, transient or fixed third degree AV block
History of documented ventricular flutter, ventricular fibrillation, Torsade de Pointes tachycardia
Patients who had previously received anthracyclines or other known cardiotoxic medication
Women with breast implants as these may have interfered with the recording of the ECG
Patients with severe electrolyte abnormalities and patients in whom transient electrolyte abnormalities may have been expected during any visit of the study
Patients in whom concomitant neurotropic drug therapy was known to change or was likely to change during the course of the study, where such therapy was likely to affect the patients ERG measurement
Ophthalmic conditions where in the opinion of the investigator they might affect the recording of the ERG