Phase 1 OL study of AZD0156 monotherapy or with combination therapies
Research type
Research Study
Full title
A Phase 1, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD0156 Monotherapy or in Combination with either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients with Advanced Malignancies
IRAS ID
185024
Contact name
Ginette Hampshire
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-002572-25
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Summary of Research
This study is part of a research project for collecting information about the safety and effectiveness of AZD0156 which is a new anti-cancer treatment. The main purpose of the study is to establish a safe dose of the study drug when given at the same time as olaparib by gathering information on how well it is tolerated, any potential side effects it may cause and collecting data about how the cancer responds to the study drug. The study will also measure the levels of AZD0156 and olaparib in the blood and the action of AZD0156 in the body over a period of time. It will also indicate whether the study drug has an effect on this type of cancer. It is hoped that the combination of both AZD0156 and olaparib may result in an increase in cancer cells dying and so stop or reduce cancer growth.
Summary of Results
The study drug, AZD0156, was designed to stop kinases from helping cancer to spread. In this study, the researchers wanted to learn more about the safety of AZD0156. The researchers asked for the help of men and women who had advanced cancer. The participants in this study were 30 to 79 years old when they joined.
The study included 84 participants in South Korea, Spain, the United Kingdom, and the United States.This was an “open-label” study. This means the participants, researchers, study doctors, and other study staff knew what each participant was taking. Parts 1, 2, 3, and 4 were planned to be “dose-escalation” parts. This means that the first participants started out taking low doses of AZD0156 and olaparib. The study doctors looked at the results for these participants. Then, the researchers decided whether to increase the doses in the next participants. But, Parts 3 and 4 were not dose-escalation parts because the researchers ended the study early. This study had 4 parts. Each participant could be in only 1 part. The participants in Parts 1, 2, and 3 took AZD0156 and a cancer treatment called olaparib as tablets by mouth. The participants in Part 4 took AZD0156 as a tablet by mouth. They also received a cancer treatment called irinotecan through a needle under the skin, also called an injection. The participants got study treatment in periods of 2 weeks, 3 weeks, or 4 weeks.
In this study overall, the most common adverse event was nausea. The most common serious adverse event was blockage in the intestines.
Part 1: 96.4% of participants had adverse events. This was 54 out of 56 participants.10.7% of participants stopped treatment due to adverse events. This was 6 out of 56 participants. 41.1% of participants had serious adverse events. This was 23 out of 56 participants. There were 5.4% of participants who died due to serious adverse events. This was 3 out of 56 participants. The serious adverse events were: blockage in the intestines and blockage in the tubes connecting the liver, gallbladder, and small intestine. The study doctors did not think that these deaths were related to AZD0156.
Part 2: 94.1% of participants had adverse events. This was 16 out of 17 participants.
5.9% of participants stopped treatment due to adverse events. This was 1 out of 17 participants. 29.4% of participants had serious adverse events. This was 5 out of 17 participants. None of the participants died due to serious adverse events.Part 3: 100.0% of participants had adverse events. This was 3 out of 3 participants.
None of the participants stopped treatment due to adverse events. 33.3% of participants had serious adverse events. This was 1 out of 3 participants. None of the participants died due to serious adverse events.Part 4: 100.0% of participants had adverse events. This was 7 out of 7 participants.
14.3% of participants stopped treatment due to adverse events. This was 1 out of 7 participants. 42.9% of participants had serious adverse events. This was 3 out of 7 participants.Some of the participants had more than 1 serious adverse reaction. None of the participants in Part 3 had serious adverse reactions. There were 14.3% of participants in Part 4 who died due to serious adverse reactions. This was 1 out of 7 participants. This serious adverse reaction was bleeding in the brain. None of the participants in Parts 1, 2, or 3 died due to serious adverse reactions.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0691
Date of REC Opinion
20 Oct 2015
REC opinion
Further Information Favourable Opinion