Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

MTD - maximum tolerated dose

Inclusion Criteria:

• Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
• Subjects who have overall good overall general condition.
• Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15.
• Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
• Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits

Exclusion Criteria:

• Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib.
• Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).
• Subjects with symptomatic uncontrolled brain metastases.
• Subjects with myelodysplastic syndrome/acute myeloid leukaemia.
• Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.