At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Olaparib +2 moredrug
Likely dose
Olaparib 150mgfrom 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, 2 Part Study to Determine the Pharmacokinetics of Olaparib 300 mg bd Administered as Monotherapy and Olaparib 100 mg bd as Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours
In Brief
A Phase 1 clinical trial evaluating Olaparib and Paclitaxel for Advanced Solid Tumours. Completed, enrolled 36 participants across 3 sites.
Detailed Summary
This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumours
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartJun 2015
Primary CompletionJul 2016
Study CompletionApr 2017
TodayJul 2026
First PostedApr 30, 2015
Enrollment StartJun 10, 2015
Primary CompletionJul 27, 2016
Study CompletionApr 28, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.2 years ago
Interventions
Olaparibdrug
Tablet-150mg, Oral
Paclitaxeldrug
Injection
Olaparibdrug
Tablet-100mg, Oral