A Phase 1 interventional study of INCA033989 and Ruxolitinib in Myeloproliferative Neoplasms, sponsored by Incyte Corporation. Active, not recruiting at 28 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment
This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
626 studies on the registry are indexed under Myeloproliferative Disorders; 109 are open to participants now.
This study's enrollment of 160 is above the median of 45 across 439 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) will enroll in this group.
Drug: INCA033989
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with with essential thrombocythemia (ET) will enroll in this group.
Drug: INCA033989
INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.
Drug: INCA033989 · Drug: Ruxolitinib
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
Drug: INCA033989
INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.
Drug: INCA033989 · Drug: Ruxolitinib
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
Drug: INCA033989
INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.
Drug: INCA033989 · Drug: Ruxolitinib
INCA033989 will be administered at protocol defined dose.
Rux will be administered according to Prescribing Information/SmPC.
Also known as: Jakafi
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with ruxolitinib
Time frame: Up to 3 years and 60 days
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Time frame: Up to 3 years and 60 days
Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
Time frame: Up to 3 years and 60 days
Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
Time frame: Up to 3 years and 60 days
Participants with MF with symptomatic anemia: Anemia Response
For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol.
Time frame: Up to 3 years and 60 days
Participants With ET: Response Rate
Defined as the proportion of participants with Complete Response or Partial Response when treated with study drug.
Time frame: Up to 3 years and 60 days
Participants With ET: Mean change from baseline of total symptom score (TSS)
Mean change of TSS from baseline.
Time frame: Up to 3 years and 60 days
Mean change in disease-related allele burden
Mean change in disease-related allele burden.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Cmax of INCA33989
Defined as maximum observed plasma concentration of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Tmax of INCA033989
Defined as the time to reach the maximum plasma concentration of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Cmin of INCA33989
Defined as the minimum observed plasma concentration of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: AUC(0-t) of INCA33989
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA33989
Defined as the area under the concentration-time curve from 0 to infinity of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: CL/F of INCA33989
Defined as the apparent oral dose clearance of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Vz/F of INCA33989
Defined as the apparent oral dose volume of distribution of INCA33989.
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: t1/2 of INCA33989
Defined as the apparent terminal phase disposition half-life of INCA33989.
Time frame: Up to 3 years and 60 days
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Incyte Corporation