Status:
COMPLETED
Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Cancer
Advanced Solid Malignancies
Eligibility:
All Genders
20-130 years
Phase:
PHASE1
Brief Summary
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 pharmacokine...
Detailed Description
MTD - maximum tolerated dose
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01813474
Start Date
March 25 2013
End Date
August 31 2016
Last Update
January 16 2018
Active Locations (3)
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1
Research Site
Chūōku, Japan, 104-0045
2
Research Site
Fukuoka, Japan, 811-1395
3
Research Site
Sapporo, Japan, 003-0804