Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO) - High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS) - ECOG of 0 or 1.
- - Subjects who are positive for p53 mutation (Arm 1) - Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1) - Prior treatment with any JAK inhibitor.
- - Prior splenectomy.
- - Splenic irradiation within 24 weeks prior to randomization.
- - Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant.
- - History of major organ transplant.
- - Grade 2 or higher QTc prolongation.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Kartos Therapeutics, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belarus, Bulgaria, Georgia, Mexico, Poland, Russian Federation, South Africa, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)|
Experimental: Arm 1
KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
Experimental: Arm 2
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
Drug: - KRT-232
KRT-232, administration by mouth
Drug: - TL-895
TL-895, administration by mouth
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.