CC-90011-ST-001
Research type
Research Study
Full title
A Phase 1, Open-label, Dose finding Study to Asssess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects with Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
IRAS ID
207150
Contact name
Johann S de Bono
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2015-005243-13
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Summary of Research
Study of CC-90011-ST-001 in subjects with advanced cancer, which has not responded or has returned after standard therapy, to determine its safety and preliminary efficacy.
CC-90011 is an experimental drug that inhibits LSD1 (lysine-specific demethylase 1A), a molecule that regulates the function of many genes important in cancer progression and cell growth. Laboratory and animal studies show that CC-90011 inhibits LSD1 and delays and inhibits cancer growth.
CC-90011 is being given to people for the first time and will be studied in sites experienced in such trials. The study aim is to determine the safety and highest safe dose for further testing, to evaluate any effect on the cancer and how the body handles CC-90011.
Men and women at least 18 years old, with advanced cancer or Non-Hodgkin’s Lymphoma that has not responded, or has returned after treatment, or for whom no other treatment exists or is acceptable, will be enrolled.
The study has 2 parts, dose escalation (Part A) and expansion (Part B).
Part A will test increasing doses of CC 90011 to determine the highest safe dose. Participants who enroll `first will be assigned the lowest dose of CC 90011. Once that dose level is considered safe and acceptable, additional patients will be assigned to a higher dose level. This will continue until the highest safe dose level has been studied.
Part B will evaluate the highest or near-highest safe dose of CC-90011 in specific cancers.
Participants will have regular safety blood tests, tests to see how long CC-90011 stays in the body and its effect on their tumour and will be frequently assessed for adverse effects.
125 participants will be enrolled in UK, France and USA; the study is sponsored by Celgene Corporation.The study duration is approximately 5 years.REC name
London - Central Research Ethics Committee
REC reference
16/LO/1082
Date of REC Opinion
4 Jul 2016
REC opinion
Favourable Opinion