Advanced Cancer Clinical Trial
Official title:
An Open-label, Multi-centre, Single-dose Clinical Trial to Assess the Pharmacokinetic (PK) Properties and Tolerability of a Single Oromucosal Dose of 6 Sprays of Sativex® in Patients With Advanced Cancer Currently on Background Step III Opioid Therapy
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.
This is an open-label, multiple-centre, single dose clinical trial to assess the PK of a
single oromucosal dose of Sativex in subjects with advanced cancer who are currently on
background Step III opioid therapy.
A minimum of 25 subjects ≥18 years with advanced cancer will be needed for the assessment of
the primary objective of the trial. The Screening Visit (Visit 1) will be performed within
-10 to -2 days prior to dosing. For the Screening Visit, subjects will attend on an
outpatient basis.
Subjects will be checked into the clinical research facility on Day −1 and will be confined
to the clinical research facility for the Inpatient/Treatment Period (Day −1 to Day 3)
(Visit 2). Subjects will be administered a single oromucosal dose of Sativex on Day 1 (time
[t]=0). Fourteen PK blood samples will be taken from Day 1 to Day 3 during Visit 2: one
predose sample and 13 postdose samples at the following time points after dosing: 0.25, 0.5,
0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours postdose.
Subjects will be discharged from the clinical research facility after the 48-hour PK blood
sample has been taken and final safety assessments are completed. Subjects who discontinue
from the trial prior to the completion of the PK blood draws will undergo the safety
evaluations scheduled for Day 3.
The Safety Follow-up Call (Visit 3) will be made 7 (+2) days after dosing on Day 1. Subjects
with any new adverse events (AEs) or clinical laboratory abnormalities will be asked to
return for safety follow-up.
The expected duration for trial participation (including Screening Visit,
Inpatient/Treatment Period, and Safety Follow-up Call) for each individual subject is a
maximum of 19 days.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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