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Clinical Trial Finder

Search Results

IMG-7289 in Patients With Essential Thrombocythemia

Study Purpose

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with essential thrombocythemia. This study investigates the following:

  • - The safety and tolerability of IMG-7289.
- The pharmacodynamic effect of IMG-7289

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
- Pregnant or lactating females

Trial Details

Trial ID:

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.

NCT04254978
Phase

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.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Imago BioSciences,Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hugh Rienhoff, MD
Principal Investigator Affiliation Imago BioSciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Germany, Hong Kong, Italy, New Zealand, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Essential Thrombocythemia
Additional Details

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.

Arms & Interventions

Arms

Experimental: IMG-7289

IMG-7289 administered daily for 169 consecutive days

Interventions

Drug: - IMG-7289

LSD1 inhibitor

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.

Local Institution, Jacksonville, Florida

Status

Recruiting

Address

Local Institution

Jacksonville, Florida, 32209

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Ann Arbor, Michigan

Status

Recruiting

Address

Local Institution

Ann Arbor, Michigan, 48109

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, New York, New York

Status

Recruiting

Address

Local Institution

New York, New York, 10021

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Durham, North Carolina

Status

Recruiting

Address

Local Institution

Durham, North Carolina, 27710

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Trinity Samson

TaussigResearch@ccf.org

1-415-529-5055

Local Institution, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Local Institution

Pittsburgh, Pennsylvania, 15232

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Seattle, Washington

Status

Recruiting

Address

Local Institution

Seattle, Washington, 98109

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

International Sites

Local Institution, Herston, Brisbane, Australia

Status

Recruiting

Address

Local Institution

Herston, Brisbane,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Camperdown, New South Wales, Australia

Status

Recruiting

Address

Local Institution

Camperdown, New South Wales,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, St Leonards, New South Wales, Australia

Status

Recruiting

Address

Local Institution

St Leonards, New South Wales, 2065

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Southport, Queensland, Australia

Status

Recruiting

Address

Local Institution

Southport, Queensland,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

Chris Hoare

christine.hoare@sa.gov.au

1-415-529-5055

Local Institution, Clayton, Victoria, Australia

Status

Recruiting

Address

Local Institution

Clayton, Victoria, 3168

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Essen, Germany

Status

Recruiting

Address

Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)

Essen, , 45147

Site Contact

Joachim Göthert

joachim.goethert@uk-essen.de

1-415-529-5055

Local Institution, Jena, Germany

Status

Recruiting

Address

Local Institution

Jena, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Hong Kong, Hong Kong

Status

Recruiting

Address

Local Institution

Hong Kong, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Alessandria, Italy

Status

Recruiting

Address

Local Institution

Alessandria, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Bologna, Italy

Status

Recruiting

Address

Local Institution

Bologna, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Florence, Italy

Status

Recruiting

Address

CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi

Florence, , 50139

Site Contact

Chiara Paoli

CRIMM@aou-careggi.toscana.it

1-415-529-5055

Local Institution, Varese, Italy

Status

Recruiting

Address

Local Institution

Varese, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Auckland, New Zealand

Status

Recruiting

Address

Local Institution

Auckland, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Middlemore Hospital, Auckland, New Zealand

Status

Recruiting

Address

Middlemore Hospital

Auckland, ,

Site Contact

Katie Seto

Katie.Seto@mmclintrials.nz

1-415-529-5055

Local Institution, London, United Kingdom

Status

Recruiting

Address

Local Institution

London, , NW1

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Guys and St Thomas Hospital, London, United Kingdom

Status

Recruiting

Address

Guys and St Thomas Hospital

London, , SE1 9RT

Site Contact

Claire Harrison

Claire.Harrison@gstt.nhs.uk

1-415-529-5055

Local Institution, London, United Kingdom

Status

Recruiting

Address

Local Institution

London, , W12

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

Local Institution, Oxford, United Kingdom

Status

Recruiting

Address

Local Institution

Oxford, ,

Site Contact

jennifer.peppe@imagobio.com

1-415-529-5055

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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