Trial of Olaparib in Combination With AZD5363 (ComPAKT)

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT02338622
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    olaparib BD
  • AZD5363 — DRUG
    AZD5363 BD

Study Details

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).

Key Dates

Start date
Mar 31, 2014
Status verified
Jan 2020
Primary completion
Mar 21, 2016
Completion
Mar 21, 2017

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Schedule A: 4 days on, 3 days off
    300mg olaparib + intrapatient dose escalation of AZD5363 4 days on, 3 days off Schema for dose escalation in schedule A (4-days-on, 3-days-off AZD5363) -1. Olaparib: 200mg, AZD5363 240mg 1. Olaparib: 300mg, AZD5363 320mg 2. Olaparib: 300mg, AZD5363 400mg 3. Olaparib: 300mg, AZD5363 480mg
  • Experimental: Schedule B: 2 days on, 5 days off
    300mg olaparib + intrapatient dose escalation of AZD5363 2 days on, 5 days off Schema for dose escalation in schedule B (2-days-on, 5-days-off AZD5363) -1. Olaparib: 200mg, AZD5363 400mg 1. Olaparib: 300mg, AZD5363 480mg 2. Olaparib: 300mg, AZD5363 560mg 3. Olaparib: 300mg, AZD5363 640mg

Primary Outcome Measure

Safety/tolerability of olaparib in combination with AZD5363 [ Time Frame: 3 to 9 weeks at least. ]

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