INCA033989
DrugINCA033989 will be administered at protocol defined dose.
NCT Number: NCT05936359
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Royal Brisbane and Women'S Hospital, Herston, Queensland, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined Inclusion/Exclusion Criteria may apply.
INCA033989 will be administered at protocol defined dose.
Rux will be administered according to Prescribing Information/SmPC.
Other names: Jakafi
Time frame: Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 3 years and 60 days
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.
Time frame: Up to 3 years and 60 days
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
Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
Time frame: Up to 3 years and 60 days
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
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
Mean change of TSS from baseline.
Time frame: Up to 3 years and 60 days
Mean change in disease-related allele burden.
Time frame: Up to 3 years and 60 days
Defined as maximum observed plasma concentration of INCA33989.
Time frame: Up to 3 years and 60 days
Defined as the time to reach the maximum plasma concentration of INCA33989.
Time frame: Up to 3 years and 60 days
Defined as the minimum observed plasma concentration of INCA33989.
Time frame: Up to 3 years and 60 days
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
Defined as the area under the concentration-time curve from 0 to infinity of INCA33989.
Time frame: Up to 3 years and 60 days
Defined as the apparent oral dose clearance of INCA33989.
Time frame: Up to 3 years and 60 days
Defined as the apparent oral dose volume of distribution of INCA33989.
Time frame: Up to 3 years and 60 days
Defined as the apparent terminal phase disposition half-life of INCA33989.
Contact information is provided by the study sponsor or research team.
Incyte Corporation Call Center (US)
CONTACT
Incyte Corporation Call Center (ex-US)
CONTACT
Incyte Corporation
Industry
A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07441694
Blood Coagulation Disorders, Blood Platelet Disorders
Birmingham, Alabama, United States
View Trial DetailsNCT07008118
Blood Coagulation Disorders, Blood Platelet Disorders
Phoenix, Arizona, United States
View Trial DetailsNCT06034002
Blood Coagulation Disorders, Blood Platelet Disorders
Duarte, California, United States
View Trial DetailsNCT07362225
Accelerated Phase MPN, Accelerated Phase Myeloproliferative Neoplasm
Chicago, Illinois, United States
View Trial Details