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Southampton Clinical Trials Unit

ProCAID (Phase II)

Title

An open label phase I/randomised, double blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 In combination with Docetaxel and prednisolone chemotherapy  

Description

A phase I/II trial to determine if the addition of the AKT inhibitor AZD5363 to docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in metastatic castration resistant prostate cancer (mCRPC) to a degree worthy of further investigation.

Objectives

Primary Endpoints:

  • Phase I
    • Determination of a suitable dose of AZD5363 using a 4 days on/3 days off continuous schedule, in combination with DP
  • Phase II
    • Progression free survival (PFS) in patients receiving AZD5363 versus placebo when combined with DP in mCRPC

Secondary Endpoints:

  • Phase I 
    • Safety and tolerability profiles using CTCAE version 4.03
    • AZD5363 pharmacokinetics in combination with DP
  •  Phase II
    • Overall survival
    • Bone pain changes using the brief pain inventory
    • PFS excluding biochemical (PSA) alone progression
    • Biochemical (PSA) response rates according to PCWG2 criteria
    • Safety and tolerability profiles using CTCAE version 4.03

Trial Design

ProCAID will first comprise a dose-finding, single arm, open label phase I study exploring the combination of AZD5363 and Docetaxel and prednisolone chemotherapy (DP). This will be followed by a double-blind, randomised phase II study comparing DP + AZD5363 with DP + placebo. All patients will have chemotherapy naive mCRPC and will be suitable for treatment with palliative docetaxel. Patients may, but are not required to, have had prior second generation anti-hormonal therapies (e.g., abiraterone, enzalutamide).

  • Phase I
    • AZD5363 at dose levels between 320 mg bd and 480 mg bd, taken 4 days on/3 days off, continuously starting from day 2 of cycle 1 of DP onwards.
  • Phase II
    • AZD5363 twice daily at a dose level  defined in phase I (experimental arm) or matching placebo (control arm), taken 4 days on/3 days off, continuously from day 2 of cycle 1 of DP onwards.

Trial Status

Closed to recruitment - In Follow up

Population

Metastatic castration resistant prostate cancer (mCRPC) patients suitable to receive palliative docetaxel chemotherapy

Phase I: 3-18 patients

Phase II: 132 (66 per arm)

 

 

Trial Team:

Senior Trial Manager:

Ellice Marwood (023 8120 5608)

Trial Manager:

Nicky Downs (023 8120 5302)

Clinical Data Coordinator:

Mary Ellis (023 8120 5698)

Contact information

Email: procaid@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting: ctu@soton.ac.uk or 0844 7740 621

 

Essential Trial Documents

ProCAID - Protocol v12 20-Mar-2019

ProCAID - AZD5363 IB Edition 10

ProCAID - Patient Information Sheet Phase II v8 21-Jun-2018

ProCAID - Informed Consent Form Phase II v8 21-Jun-2018

ProCAID - GP Letter Phase II v6 21-Jun-2018

ProCAID - Phase II - Patient Diary 21 Day Cycle v3 20-Mar-2019

ProCAID - Phase II - Patient Diary Additional Week v3 20-Mar-2019

ProCAID - Phase II - Patient Diary 21 Day Cycle GUIDANCE

ProCAID - Phase II - Patient Cards v2 22-Aug-2017

ProCAID - Brief Pain Inventory v2 02-Feb-2018

ProCAID - Phase II - Brief Pain Inventory Diagram Scoring System v1 08-Ot-2015

Pharmacy Documents

ProCAID - Phase II - Pharmacy Manual v1 17-Jul-2015

ProCAID - Pharmacy File Index v2 17-Sep-2015

ProCAID - Phase II - Drug Accountability Log v1 27-Jan-2015

ProCAID - Phase II - Drug Destruction Log v1 27-Jan-2015

Investigator Site File

ProCAID - Study Contacts and Information Page v4 02-Oct-2015

ProCAID - ISF Index v4 09-Oct-2015

ProCAID - Master Patient List v2 27-Aug-2014

ProCAID - Screening Log v3.0 02-Nov-2015

ProCAID - Labels for Patient Records L7173 v2 27-Aug-2014

ProCAID - Site Visit Log v2 27-Aug-2014

ProCAID - Delegation Log V3 22-Mar-2016

SAE Documents

ProCAID - Phase II - SAE/SUSAR Report Form v4 15-Sep-2016

ProCAID - Instructions for completion of Serious Adverse Event Reporting v2 04-May-2017

ProCAID - Phase II - SAE/SUSAR Follow-Up Form v1.0 08-Oct-2015

ProCAID - Phase II - Section E Continuation SAE/SUSAR Report Form v1 08-Oct-2015

IWRS (Cenduit)

ProCAID - IWRS Training Certificate v3 20-Dec-2016

ProCAID - Site, Investigator and Pharmacist User Guide v4

eCRF (RAVE)

ProCAID - Phase II - eCRF Completion Guidance v3 15-Nov-2018

Translational Sample Documents

ProCAID - Phase II - Sample Collection Guidance v1 14-Oct-2015

ProCAID - Sample Storage and Shipment Log v2 27-Aug-2014

ProCAID - Central Laboratory Contact Information v1 10-Feb-2014

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