Advanced Solid Tumours Clinical Trial
Official title:
A Phase I, Open-Label, Multicentre Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD2811 in Patients With Advanced Solid Tumours.
This Phase I study is primarily designed to evaluate the safety and tolerability of AZD2811 at increasing doses in patients with advanced solid tumours and for whom no standard of care exists. The study will be conducted in two parts, a dose-escalation phase (Part A) and a dose expansion phase (Part B). During Part A, the dose-escalation phase, patient enrolment will proceed according to a 3+3 design where the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) could be identified. The study will also characterize the pharmacokinetic (PK) profile of AZD2811 and will explore the potential biological activity by assessing anti-tumour activity in patients. Part B will further explore PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD2811 RP2D as monotherapy (Group 1) in patients with relapsed/refractory SCLC.
This is a first-time-in-patient (FTIP) study with the nanoparticle formulation of AZD2811
primarily designed to evaluate the safety and tolerability of AZD2811 at increasing doses in
patients with advanced solid tumours and for whom no standard of care exists.
The study will be conducted in two parts: Part A dose-escalation and Part B dose-expansion.
In Part A, the dose-escalation phase, patient enrolment has proceeded according to a 3+3
design in order to identify the maximum-tolerated dose (MTD) or recommended Phase 2 dose
(RP2D). AZD2811 monotherapy has been administered IV to patients with advanced solid tumours
on Days 1 and 4 of a 28-day cycle in 6 dose levels without any relevant toxicities in the
first 5 patient cohorts. In Cohort 6 (200 mg), grade 4 asymptomatic neutropenia was observed,
and a dose-limiting toxicity was observed in 1 patient of the 5 evaluable patients. In Cohort
7 AZD2811 (200 mg) was given on Day 1 only of a 28-day cycle; in Cohort 8 AZD2811 (200 mg)
was given on Day 1 only of a 21-day cycle. In Cohort 9, the AZD2811 dose was escalated to 400
mg on Day 1 every 21 days.
The Safety Review Committee (SRC) will review the safety and tolerability of AZD2811 for each
cohort and schedule to determine the next cohorts. The study will also characterize the
pharmacokinetic (PK) profile of AZD2811 and will explore potential biological activity by
assessing anti-tumour activity in patients.
Once the MTD is established, Part B the dose expansion phase will continue to explore PK
parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD2811 RP2D as
monotherapy in 21 patients with relapsed/refractory SCLC.
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