| Exclusion Criteria: | 1) Patients who have had any treatment for their disease or high dose radiotherapy less than 28 days from active study therapy. Patients may continue concomitant use of bisphosphonates if used for at least 28 days prior to commencing study treatment and patients may receive palliative radiotherapy for bone disease during the study.
2) Patients requiring treatment with inhibitors or iducers of CYP3A4.
3) Patients with brain metastases.
4) Any other malignancy which has been active or treated within the past 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions. Patients with a history of breast cancer are not eligible if the disease was diagnosed within the past 5 yars except for adequately treated stage I or II breast cancer who received definitive treatment more than 5 years before screening can participate even if they received adjuvant treatment during the 5 years prior to screening.
5) Persistent CTC grade 2 or greater toxicities (excluding alopecia) caused by prior therapy.
6) Patients currently experiencing seizures or who are currently treated with any antiepileptic for seizures (use of anti-epileptic drugs to control pain is allowed in patients not suffering from seizures unless drug is excluded due to CYP3A4 induction - phenytoin, carbamazepine, phenobarbitone).
7) Major thoracic and/or abdominal surgery in the four weeks prior to the start of study treatment.
8) Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
9) Presence of gastrointestinal disorders [Clarification: Patients with abnormal bowel function (i.e. inability to tolerate oral medication without nausea or vomiting] that, in the Investigator's opinion, are likely to interfere with the absorption of the IMP.
10) Patients who are unable to swallow orally administered medication
11) Patients who are immunocompromised, e.g. patients known to be serologically positive for human immunodeficiency virus (HIV).
12) Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used (lack of childbearing potential is met by being postmenopausal, being surgically sterile, practising contraception with an oral contraceptive or other hormonal therapy [e.g. hormone implants], intra-uterine device, diaphragm with spermicide or condom with spermicide, or being sexually inactive. Patients and their partners must agree to use one of the above forms of contraception throughout the treatment period and for 3 months after discontinuation of treatment).
13) Simultaneous participation in any other study involving an investigational medicinal product (IMP), or having participated in a study less than 28 days prior to the start of study treatment. |