The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

Exclusion Criteria

• •1. Involvement in the planning and/or conduct of the study.
• •2. Previous enrolment in the present study.
• •3. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
• •4. Any previous treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor, including olaparib.
• •5. Patients with other malignancy within the last 5 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1, Grade 1 endometrial cancer, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.
• •6. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. These include patients with gastric or intestinal cancer or patients with prior surgical procedures such as full or partial gastrectomy.
• •7. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study treatment.
• •8. Concomitant use of known potent CYP3A4 (Cytochrome P450 3A4) inhibitors.
• •9. Patients with any ongoing toxicities (\>CTCAE (Common Terminology Criteria for Adverse Events) grade 2), with the exception of alopecia, caused by previous cancer therapy.
• •10. Resting ECG with QTc (Heart Rate Corrected QT interval) \> 470msec or family history of long QT syndrome.
• •11. Patients with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
• •12. Patients with myelodysplastic syndrome/acute myeloid leukaemia.
• •13. Patients with symptomatic uncontrolled brain metastases.
• •14. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
• •15. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• •16. Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• •17. Patients with known active hepatic disease (i.e. Hepatitis B or C).
• •18. Patients with a known hypersensitivity to olaparib, paclitaxel or any of the excipients of the product.
• •19. Breastfeeding women.
• •20. Clinical judgement by the investigator that the patient should not participate in the study.