A Phase 1, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
- Conditions
- Cancer, Advanced Solid Malignancies
- Registration Number
- JPRN-jRCT2080222063
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method