AZD5305 as monotherapy and in combination with anti-cancer agents
Research type
Research Study
Full title
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (PETRA)
IRAS ID
295239
Contact name
Adam Sharp
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-002688-77
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 2 days
Research summary
This research study is designed to see if experimental treatment with AZD5305 alone, or in combination with anti-cancer drugs, is safe and tolerable and works in treating advanced solid tumours. The study will help to better understand the studied disease and associated health problems. 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 the best safe and tolerable dose of AZD5305.
The study will also evaluate how much of the study drug is in the blood at various times. In addition, the action of the drug will be evaluated by measuring specific molecules in the blood.
The study will be conducted in different modules. Module 1 will look at AZD5305 alone, Module 2 will look at AZD5305 in combination with paclitaxel and Module 3 will look at AZD5305 in combination with carboplatin with or without paclitaxel. Carboplatin and paclitaxel are approved chemotherapy drugs used to treat different cancers, including ovarian and breast cancers. Each Module has 2 study parts: Part A consisting of dose-escalation cohorts and Part B, consisting of expansion cohorts. About 612 participants will take part in the study overall, with plans to recruit approximately 50 participants from 4 sites within the UK.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0263
Date of REC Opinion
11 May 2021
REC opinion
Further Information Favourable Opinion