PETRANHA
Research type
Research Study
Full title
A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patients with Metastatic Prostate Cancer (PETRANHA)
IRAS ID
1004844
Contact name
Varadamurthy Srinivasan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-006289-19
Clinicaltrials.gov Identifier
Research summary
This research study is designed to see if experimental treatment with AZD5305 in combination with new hormonal agents (NHAs), is safe, tolerable and works in treating metastatic prostate cancer.
NHAs aim to slow the growth of tumours. AZD5305 is a type of drug known as a PARP inhibitor. PARP inhibitors are a type of targeted cancer drugs. PARP is a protein found in our cells and it stands for poly-ADP ribose polymerase. It helps damaged cells to repair themselves. As a cancer treatment, PARP inhibitors stop the PARP from doing its repair work in cancer cells resulting in cell death. PARP inhibitors are approved for the treatment of some patients with ovarian, breast, pancreatic and prostate cancer. AZD5305 is different from currently available PARP inhibitors as it has been shown to more selectively target certain PARP proteins.
The main purpose of this study is to determine a safe and effective dose of AZD5305 when given with an approved NHA (either enzalutamide, abiraterone acetate, or darolutamide).
The study will also evaluate how much of the study drug is in the blood at various times and the action of the drug will be evaluated by measuring specific molecules in the blood.
Participants will be assigned to 1 of 3 arms decided by the treating study doctor:
Arm 1: AZD5305 in combination with enzalutamide
Arm 2: AZD5305 in combination with abiraterone acetate
Arm 3: AZD5305 in combination with darolutamide
Cohort 1 in each arm will have a pre-planned dose of the medication combination and additional cohorts may be started to explore different doses or schedules of AZD5305 in combination with an NHA, depending on emerging safety data or data about how much study drug is in the blood.
About 140 participants will take part in the study, with plans to recruit approximately 62 participants from 6 sites within the UK.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0213
Date of REC Opinion
28 Apr 2022
REC opinion
Further Information Favourable Opinion