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

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) ]

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