Trial of Olaparib in Combination With AZD5363 (ComPAKT)
Status:
Completed
Trial end date:
2017-03-21
Target enrollment:
Participant gender:
Summary
This is a phase I trial of the combination of the PARP inhibitor olaparib and AKT inhibitor
AZD5363.
There are two parts to this study. Part A: dose escalation, and Part B: dose expansion.
Part A will investigate the combination of 300 mg bd of olaparib with intrapatient ascending
doses of AZD5363 administered for either 4-days-on, 3-days-off, and 2-days-on, 5-days-off.
Once the Maximum Tolerated Dose (MTD) is reached for both arms (or under the advice from the
Safety Review Committee (SRC) one of the schedules will be discontinued), the schedule with
the optimum safety and PK/PD profile will be taken forward to a dose expansion phase (Part
B).
Part B will evaluate the optimized dose/schedule identified in Part A of the study in
patients with (1) BRCA1/2 mutant cancers (with previous disease progression on PARP inhibitor
monotherapy), or (2) advanced sporadic tumours (e.g. TNBC, CRPC, HGSOC and tumours with
somatic mutations or other aberrations known to result in a hyperactivated PI3K-AKT pathway).
Phase:
Phase 1
Details
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborators:
AstraZeneca Institute of Cancer Research, United Kingdom