At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
olaparibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
In Brief
A Phase 1 clinical trial evaluating olaparib for Cancer and Advanced Solid Malignancies. Completed, enrolled 23 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Advanced Solid Malignancies
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartMar 2013
Primary CompletionAug 2016
TodayJul 2026
First PostedMar 19, 2013
Enrollment StartMar 25, 2013
Primary CompletionAug 31, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.3 years ago
Interventions
olaparibdrug
tablet oral