The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

Sponsor
AstraZeneca
Study ID
NCT02430311
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Tablet-150mg, Oral
  • Paclitaxel — DRUG
    Injection
  • Olaparib — DRUG
    Tablet-100mg, Oral

Study Details

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

Key Dates

First listed
Apr 30, 2015
Start date
Jun 10, 2015
Status verified
Jul 2019
Primary completion
Jul 27, 2016
Completion
Apr 28, 2017

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Treat 15 patients, single dose olaparib 300mg followed by multiple dose olaparib 300mg twice a day
  • Experimental: Cohort 2
    Treat 15 patients, single dose olaparib 100mg followed by multiple dose olaparib 100 mg twice a day and then in combination with paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle)

Primary Outcome Measure

Single Dose PK Parameter--Cmax [ Time Frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3) ]

Related Studies