| Exclusion Criteria: | 1) Less than 28 days from active therapy (i.e., any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use bisphosphonates if started prior to commencing study treatment and patients may receive palliative radiotherapy for bone disease during the study).
2) Prior treatment with liposomal doxorubicin.
3) Prior treatment with anthracyclines as a treatment for ovarian cancer. Patients who have received anthracyclines (non-liposomal doxorubicin or epirubicin) for the treatment of breast cancer are eligible provided the lifetime cumulative dose has not exceeded 240mg/m2 or 480 mg/m2 respectively at screening.
4) Patients requiring treatment with inhibitors or inducers of CYP3A4.
5) Patients with known brain metastases.
6) Any other malignancy which has been active or treated w/in d past 5 yrs, except adequately treated cone-biopsied in situ carcinoma of the cervix uteri & non-melanoma skin lesions or endometrial carcinoma stage 1A grade 1. Pts w/a history of breast cancer are not eligible if d disease was diagnosed w/in the past 5 yrs except for adequately treated stage I or II breast cancer w/out evidence of recurrent disease. Pts w/a history of breast cancer who received definitive treatment can participate even if they received adjuvant treatment during the 5 yrs prior to screening.
7) Persistent CTC grade 2 or greater toxicities (excluding alopecia) caused by prior therapy.
8) Patients currently experiencing seizures or who are currently being treated with any anti-epileptic 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.
9) Major thoracic and/or abdominal surgery in the four weeks prior to the start of study treatment.
10) Left ventricular ejection fraction below 50%.
11) 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.
12) Presence of gastrointestinal disorders that, in the Investigator's opinion, are likely to interfere with the absorption of AZD2281 or with the patients ability to take regular oral medication.
13) Patients who are unable to swallow orally administered medication.
14) Patients who are immunocompromised, e.g., patients known to be serologically positive for human immunodeficiency virus (HIV).
15) A positive pregnancy test. 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 post-menopausal, being surgically sterile, practicing 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 & their partners must agree to use one of the above forms of contraception throughout the treatment period & for 3 months after end of treatment).
16) Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
17) Known hypersensitivity to any of the excipients in the AZD2281 or a conventional formulation of Doxorubicin HCl.
18) Previous treatment with AZD2281 or other drug with similar mode of action. |