AZ: D0816C00006 - Ph. 1 Renal Function/ Impairment
Research type
Research Study
Full title
An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients with Advanced Solid Tumours and Normal Renal Function or Renal Impairment
IRAS ID
137815
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-002225-30
ISRCTN Number
N/A
Research summary
This is a 2-part (A & B) study for patients over 18 years old with advanced solid tumours and Normal Renal (kidney) Function (NRF), Mild (MiRI) or Moderate Renal Impairment (MoRI), whose tumours have failed to respond to standard treatments.
Patients receive identical treatments.
Patients receive study drug, Olaparib, in tablet form orally.
No other study drug or placebo will be given during study.
Plan is to enrol 42 patients globally.
Patients with NRF & MiRI will recruit before MoRI.
If MiRI patient data raises safety concerns for MoRI patients, then latter will not enter study.
Part A
Investigates performance (pharmacokinetics - PK), safety and tolerance (tolerability) of Olaparib in patients with MiRI or MoRI compared to patients with NRF.Patients check into clinic on evening prior to dosing & stay overnight until 24 hours after dose of Olaparib, then return to clinic on Days 3, 4 and 5.
Patients then enter Part B to take Olaparib tablets if investigator deems appropriate & Part B patient inclusion/exclusion criteria are met.
Patients start Part B within 2 weeks (5-14 days) of dosing in Part A.
Part B
Allows patients with MiRI or MoRI or NRF continued access to Olaparib after PK phase & provides extra safety data.Patients have weekly clinic visits for 4 weeks; then monthly for 12 months.
Heart (ECG) tests, blood/urine samples are taken and Adverse/Serious Adverse Events (AEs/SAEs) recorded in Parts A & B.
Patients return to clinic for assessments, 30 days (±7 days) after last dose in Part A or after discontinuation of Olaparib in Part B.
If patient discontinues study drug during Part B, they also attend a visit.
After Part B, patients follow normal routine clinical schedules, no clinical data will be collected, except for SAEs.
During & after Part B, patients may continue to take Olaparib, if they/investigator agree it to be so.
Patients may benefit during dosing with Olaparib but is not guaranteed.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0281
Date of REC Opinion
18 Oct 2013
REC opinion
Further Information Favourable Opinion