Refractory Solid Tumours Clinical Trial
Official title:
A Phase Ib Study of AZD1775 and Olaparib in Patients With Refractory Solid Tumours
The purpose of this Phase 1b, multi-centre, dose escalation study is to find the maximum tolerated dose (MTD) of AZD1775 combined with olaparib in patients with refractory solid tumours
This is a Phase Ib, multi-centre study of AZD1775 combined with olaparib administered orally
in patients with refractory solid tumours, or as combination therapy for relapsed small-cell
lung cancer (SCLC). There are 2 parts to the study:
Part A: Dose Escalation Part B: Dose Expansion
In Part A, patients with refractory solid tumours will be assessed for safety, tolerability,
and pharmacokinetics (PK) of AZD 1775 when combined with olaparib. Different dose levels will
be administered to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D).
The dose expansion part (Part B) will further explore the safety, PK, and preliminary
efficacy of the AZD1775 RP2D and dosing schedule for the treatment of patients with SCLC who
previously had a confirmed response (either a Complete Response or Partial Response) to
first-line platinum therapy and then relapsed. Patients who progressed whilst on
platinum-containing therapy (platinum refractory) are not permitted to enter the study..
An olaparib pharmacokinetic (PK) sub-study will precede the combined treatment with AZD1775
and olaparib for all patients in Part A. In the sub-study single agent olaparib will be given
orally BID for 3 or 5 consecutive days and venous blood samples will be collected on Day 3 or
Day 5 as appropriate for assessment of the multiple dose pharmacokinetics of single agent
olaparib. Patients will experience a short gap in treatment (approximately 4-5 days) between
Day 3 or Day 5 of the olaparib PK sub-study and Cycle 1 Day 1 of the combination treatment.
Patients will continue to receive treatment with AZD1775 and Olaparib until disease
progression, intolerable toxicity, or discontinuation criteria have been met.
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