Study of ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression
Research type
Research Study
Full title
A Phase 1b/2 Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression
IRAS ID
1003851
Contact name
Christopher Caldwell
Contact email
Sponsor organisation
Aileron Therapeutics, Inc
Eudract number
2019-001848-21
Research summary
This study is being undertaken to see if the investigational study drug, ALRN-6924, can reduce certain side effects of pemetrexed and carboplatin, approved medicines used to treat some cancers including non-small cell lung cancer (NSCLC) in patients who are recently diagnosed. Investigational means that that the United States (U.S.) Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other health authorities have not approved ALRN-6924 as a treatment for any diseases.
Pemetrexed and carboplatin often cause a drop in blood cell counts, increasing the risk for infections and fever, making bleeding and bruising more likely, and sometimes causing the next cycle of treatment to be delayed. Researchers want to know if giving you ALRN-6924 before and after pemetrexed and carboplatin can make these side effects happen less often or make them less severe.
There are two parts to this study, called Part 1 and Part 2. The purpose of Part 1 was to find the best dose and schedule of ALRN-6924 to give with topotecan in patients with small cell lung cancer. The purpose of Part 2 is to evaluate the changes in blood cell counts and other side effects of pemetrexed and carboplatin given with ALRN-6924 or placebo.
About 80 patients with abnormal p53 NSCLC will take part in the Phase 1b Part 2 of the study. About 25 to 30 hospitals/institutions across Europe, United Kingdom, North America, Asia and Pacific are taking part in the study. The United Kingdom will only participate in Part 2 of the study.
REC name
HSC REC A
REC reference
21/NI/0128
Date of REC Opinion
19 Sep 2021
REC opinion
Unfavourable Opinion