Malignant Solid Tumor Clinical Trial
Official title:
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
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.
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.
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