Cancer, Advanced Solid Malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : olaparib tablet
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational m
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Outcome results
None listed