Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Signed, informed consent
Histological or cytologically confirmed malignant solid tumour refractory to standard therapy or for which no standard therapy exists
Evaluable disease
Recovered from the acute adverse effects of prior therapies (excluding alopecia and grade 1 neuropathy)

Adequate bone marrow, hepatic and renal function including the following:

Hb ≥ 9.0 g/dl, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 100x109/L
Total bilirubin ≤ 1.5 x upper normal limit
AST and ALT ≤ 2.5 x upper normal limit (or ≤ 5 x UNL in the presence of liver metastases)
Creatinine ≤1.5 x upper normal limit
Age < 18 years
Performance status (PS) < 2 (ECOG scale)
Estimated life expectancy greater than 3 months
Female patients with reproductive potential had to have a negative serum pregnancy test within 7 days of treatment. Both women and men had to agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception included IUD, oral contraceptive, sub-dermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary)

Exclusion Criteria:

Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). In patients with progressive disease (PD), continuation of LHRH agonists for prostate cancer, bisphosphonates for bone disease and corticosteroids was permitted provided the dose was stable before and during the study
Co-existing active infection or serious concurrent illness

Significant cardiovascular disease as defined by

History of congestive heart failure requiring therapy
History of unstable angina pectoris or myocardial infarction up to 6 months prior to study entry
Presence of severe valvular heart disease
Presence of a ventricular arrhythmia requiring treatment
Any co-existing medical condition that in the Investigator's judgement substantially increased the risk associated with the patient's participation in the study
Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
Gastrointestinal disorders that might have interfered with absorption of the study drug
Persistent grade 2 or greater toxicities from any cause
Patients with known brain tumours or metastases should have been excluded from this clinical study because of their poor prognosis and because they often develop progressive neurologic dysfunction that would have confounded the evaluation of neurologic and other AEs
Pregnant or breast-feeding women