CC-90009-AML-001_22 March 2017
Research type
Research Study
Full title
A Phase 1, Open-label, Dose-Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects with Relapsed or Refractory Acute Myeloid Leukaemia.
IRAS ID
232667
Contact name
Paresh Vyas
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2017-001535-39
Duration of Study in the UK
3 years, 6 months, 7 days
Research summary
Acute myeloid leukaemia (AML) is an aggressive blood cancer more commonly diagnosed in older patients. Prognosis for relapsed or refractory AML patients is poor, and conventional treatments are less effective in the elderly, so there is a need for improved treatments. This study will enrol patients with relapsed or refractory AML who are not suitable for other treatments to test a new intravenous drug, CC-90009. CC-90009 has only been tested in a few people so far in Part A of this study, but laboratory and animal tests have shown that it can slow cancer cell growth and kill cancer cells. The aim of the study is to find the right dose of CC-90009 that will be safe, most beneficial to the patient and with the minimum side effects. The study consists of 2 phases: a dose escalation phase (Part A) in which the highest safe dose is found, and an expansion phase (Part B) where the chosen dose is further tested for safety and its effect on the cancer.
Men and women, 18 years or older meeting all protocol criteria will be invited to take part.
Part A is being conducted in North America and has been open since 2016.
The UK will only participate in Part B.
Up to 20 patients will enrol at the chosen dose level(s) in Part B across 14 specialist hospitals in North America and Europe. Participants will have regular safety blood tests to see how long CC-90009 stays in the body and its effect on their cancer and bone marrow and will be frequently assessed for side effects. The study consists of screening, treatment and follow up phases and the entire study is expected to last up to 3-4 years. The study is sponsored by Celgene Corporation. Patients may withdraw consent at any time.
Lay summary of study results: Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS).REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0531
Date of REC Opinion
18 Dec 2017
REC opinion
Further Information Favourable Opinion