NCT03553108

A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.

A Phase 1, Randomised, Open-label, 4-Period Crossover Study to Develop an In Vitro-In Vivo Correlation for Olaparib Tablets in Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in subjects with solid tumours no longer responding to, or eligible for standard therapies, and for whom there are no additional standard therapies likely to benefit the subject.

Detailed description

The study is an open-label, randomised, 4-period, 4-sequence crossover pharmacokinetic study designed to generate in vivo PK data from tablet variants with different size/geometry and dose, to correlate with their corresponding in vitro dissolution profiles. The duration of each dosing period is 7 days including the washout period. Subjects will be randomised to a treatment sequence, following a balanced Latin Squares design. Twelve subjects who meet inclusion/exclusion criteria and have provided informed consent will be randomly assigned to the treatment sequences: ABCD, BDAC, CADB, or DCBA. On Day 1 of each period, subjects will receive a single dose of either Treatment A, B, C, or D, according to the randomisation schedule. Serial blood samples for determination of olaparib in plasma will be collected for up to 72 hours. Cancer subjects with advanced solid tumours are required for this study, as pre-clinical toxicology data preclude the use of olaparib in healthy volunteers. The olaparib doses chosen will deliver exposure at or below that which has been previously demonstrated to be acceptable and tolerated in cancer subjects.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	Olaparib Treatment A	Olaparib Tablet 25 mg
DRUG	Olaparib Treatment B	Olaparib Tablet 100 mg
DRUG	Olaparib Treatment C	Olaparib Tablet 150 mg
DRUG	Olaparib Treatment D	Olaparib Tablet 250 mg

Timeline

• Start date: 2018-05-16
• Primary completion: 2019-03-12
• Completion: 2020-07-01
• First posted: 2018-06-12
• Last updated: 2020-10-01

Locations

3 sites across 1 country: Belgium