A Phase 1 Study of INCA033989 alone/with Ruxolitinib in Patients With Myeloproliferative Neoplasms
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
IRAS ID
1008102
Contact name
LORI CHLYSTA
Contact email
Sponsor organisation
Incyte Corporation
Research summary
This is a Phase 1, Open-Label Study of INCA033989 administered as a treatment on its own (Monotherapy) or in combination with Ruxolitinib (Combination Therapy). We expect approx. 225 participants to be enrolled in this Study. The study has 3 parts:
•Part 1a is called dose escalation: In this part, different doses of INCA033989 will be tested to identify a safe and tolerable dose of INCA033989 as Monotherapy and as part of the Combination Therapy (if the patients have been diagnosed with myelofibrosis only) to be tested further in Part 1b. We expect to recruit approximately 75 participants.
•Part 1b is called dose expansion: In this part, the selected dose(s) from Part 1a for INCA033989 as a monotherapy or as part of a Combination Therapy will be further tested for safety, tolerability and its effect on the patient’s condition. We expect to recruit approximately 90 participants.
•Part 1c is called dose expansion: In this part, the selected monotherapy and combination dose(s) from Part 1a and further tested in Part 1b will be further tested for safety, tolerability and its effect on the patients’ disease. Patients may participate in this part only if they have been recently diagnosed with myelofibrosis and remained untreated with therapies approved for this condition so far. We expect to recruit approximately 60 participants.
Part 1c is not opening to recruitment in the UK, but may be opened after consideration of the overall benefit/risk and receiving approval to proceed from the UK health authorities. It is estimated that an individual will participate in the study for a minimum of 24 weeks, with an average participation of approx. 12 months, made up of 28 days for screening and then continuous treatment in consecutive 28-day cycles, followed by 60 days for safety follow-up. Participants will remain in the study as long as they are deriving benefit from study treatment per investigator discretion and have not met any criteria for study treatment discontinuation.REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0358
Date of REC Opinion
30 Nov 2023
REC opinion
Further Information Favourable Opinion