Clinical trial NCT01813474: Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Advanced Solid Malignancies
Keywords: Cancer
Tumour
Solid Malignancies
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

Detailed description: MTD - maximum tolerated dose

Eligibility 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:

* 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the start dose to 30 days after the last dose of study drug
Secondary outcomes:
measure: Number of Participants With Dose Limiting Toxicities
timeFrame: From the start dose to 28 days after the first dose of study drug
measure: Cmax Following Single Dosing
timeFrame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
measure: Cmax Following Multiple Dosing
timeFrame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
measure: Tmax Following Single Dosing
timeFrame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
measure: Tmax Following Multiple Dosing
timeFrame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
measure: AUC Following Single Dosing
timeFrame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
measure: AUC at Steady State Following Multiple Dosing
timeFrame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
Study officials:
affiliation: Global Medicines Development
name: Thomas Morris, M.D.
role: STUDY_DIRECTOR
References: