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|
- - Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
- - Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
- - Have failed at least one standard therapy.
- - Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.
- - Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
- - Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
- - Uncontrolled active infection.
- - Current use of prohibited medications.
- - Known HIV infection or active Hepatitis B or Hepatitis C virus infection.
- - Other hematologic/biochemistry requirements, as per protocol.
- - Use of investigational agent within last 14 days.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Hugh Rienhoff, MD|
|Principal Investigator Affiliation||Imago BioSciences|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Germany, Hong Kong, Italy, New Zealand, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of IMG-7289 administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with IMG-7289 for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive IMG-7289 in the Additional Treatment Period (ATP). Safety will be evaluated by clinical assessments of safety parameters i.e. safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures. To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.
IMG-7289 administered daily for 169 consecutive days
Drug: - IMG-7289
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.