A study assessing AZD7648 alone and in combination in Advanced Cancer
Research type
Research Study
Full title
A Phase I/IIa, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD7648 Monotherapy or in Combination with either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients with Advanced Malignancies
IRAS ID
258919
Contact name
Yvette Drew
Contact email
01912139386
Sponsor organisation
AstraZeneca AB
Eudract number
2018-003688-73
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 1 days
Research summary
The purpose of this study is to evaluate the tolerability and effects of the investigational medication AZD7648 when given orally, either alone or in combination with other selected medications, to patients with advanced cancer. We also want to know how the body handles the study medication when AZD7648 is given as a single dose and following multiple doses.
Participants may be eligible to take part in this study if they have advanced cancer. Cancer is caused by mutations (changes) in your DNA that can cause cells to grow out of control and form a tumour. The changes that happen in cancer cells can be caused when DNA breaks and repairs again. AZD7648 is an investigational study medication that targets key proteins involved in repairing damaged DNA, and we hope that this will slow or stop cancer cell growth.
This study is being sponsored by a pharmaceutical company, AstraZeneca AB, to see if AZD7648 works as an anti-cancer therapy. The study will be conducted in 3 modules:
i) In the Core Module, participants will take the study medication AZD7648 on its own. Increasing doses of AZD7648 will be tested until a dose and schedule is identified which is safe and tolerated and can be used for future studies.
ii) In Module 1, participants will take AZD7648 in combination with a chemotherapy medication called Pegylated Liposomal Doxorubicin (PLD).
iii) In Module 2, participants will take AZD7648 in combination with a study medication called Olaparib.
Each module of the study involves:
• A Screening Period which assesses a participant’s suitability.
• A Treatment Period which assesses a participant while receiving the study treatment.
• A Follow-Up Period for assessments done after participants have stopped treatment.This international study is planned to take up to 4 years and include approximately 230 participants from multiple countries including the United States and Europe.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1116
Date of REC Opinion
10 Sep 2019
REC opinion
Further Information Favourable Opinion