CPI-0610 with or without ruxolitinib
Research type
Research Study
Full title
A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Haematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myeloproliferative Neoplasms)
IRAS ID
245374
Contact name
Minal Kara
Contact email
Sponsor organisation
Constellation Pharmaceuticals, Inc
Eudract number
2018-000579-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Myelofibrosis is a bone marrow disorder that disrupts the body’s production of blood cells. The current approved treatment, ruxolitinib, has limited effects in treating the disorder so there remains a need for better treatment of myelofibrosis.\nThis is a Phase 2 study. Phase 1 has been completed. All newly enrolled participants will take part in Phase 2.\nThe aim of the study is to collect information to see if CPI-0610 is a safe and effective treatment to treat myelofibrosis.\nThe study has two groups (arms): one group of participants will be treated with CPI-0610 alone (monotherapy arm) and the other group of participants will be treated with CPI-0610 in combination with ruxolitinib (combination arm). Participants will know which arm of medication that will be given.\nThe study drug CPI-0610 has previously been tested in participants with blood cancers including myelofibrosis. CPI-0610 is a drug that inhibits of a group of proteins that are called BET proteins. By blocking BET proteins from binding to certain cancer-causing genes, CPI-0610 may result in these genes being switched off.\nRuxolitinib works by targeting proteins known as Janus kinases (JAKs). When JAKs send too many signals, they cause the body to make the wrong number of blood cells. Ruxolitinib works by targeting JAKs, which reduces overactive JAK signalling.\nCPI-0610 is anticipated to have effects in the treatment of myelofibrosis that are complementary to those of ruxolitinib. This study will test if CPI-0610 is effective alone as well when used together with ruxolitinib.\nConstellation Pharmaceuticals, Inc is the sponsor of this study which will take place in the USA, Canada, and the United Kingdom. It is anticipated that approximately 70 participants will be recruited.
REC name
West of Scotland REC 1
REC reference
18/WS/0099
Date of REC Opinion
25 Jun 2018
REC opinion
Further Information Favourable Opinion