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Clinical Trial Finder

Search Results

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib

Study Purpose

This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.

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 - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) - Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry.
  • - Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT.
  • - Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0.
  • - ECOG performance status of 0 to 2.

Exclusion Criteria:

  • - Patients who are positive for TP53 mutations.
  • - Documented disease progression or clinical deterioration any time while on ruxolitinib treatment.
  • - Patients who have had a documented spleen response to ruxolitinib.
  • - Prior splenectomy.
- Prior MDM2 inhibitor therapy or p53-directed therapy

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.

NCT04485260
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 1/Phase 2
Lead Sponsor

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

Kartos Therapeutics, Inc.
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries Australia, Bulgaria, France, Germany, Israel, Italy, Poland, Spain, United States
Conditions

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

Myelofibrosis
Arms & Interventions

Arms

Experimental: Part A, Arm 1, Cohort 1

KRT-232 by mouth once daily for Days 1-7, off treatment for Days 8-28 (28 day cycle)

Interventions

Drug: - KRT-232

administered by mouth

Drug: - Ruxolitinib

administered 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.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

[email protected]

650-542-0136

John Hopkins University, Baltimore, Maryland

Status

Recruiting

Address

John Hopkins University

Baltimore, Maryland, 21205

Site Contact

[email protected]

650-542-0136

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

[email protected]

650-542-0136

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

[email protected]

650-542-0136

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44106

Site Contact

[email protected]

650-542-0136

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Site Contact

[email protected]

650-542-0136

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

[email protected]

650-542-0136

Fred Hutchinson Cancer Research Center, Seattle, Washington

Status

Recruiting

Address

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Site Contact

[email protected]

650-542-0136

International Sites

Royal Adelaide Hospital, Adelaide, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, ,

Site Contact

[email protected]

650-542-0136

Dr. Georgi Stranski, Pleven, Bulgaria

Status

Recruiting

Address

Dr. Georgi Stranski

Pleven, ,

Site Contact

[email protected]

650-542-0136

Saint Ivan Rilski Hospital, Sofia, Bulgaria

Status

Recruiting

Address

Saint Ivan Rilski Hospital

Sofia, , 1431

Site Contact

[email protected]

650-542-0136

Sofia, Bulgaria

Status

Recruiting

Address

University Mutiprofile Hospital Alexandrovska

Sofia, , 1431

Site Contact

[email protected]

650-542-0136

CHU de Caen, Caen, Cedex 9, France

Status

Recruiting

Address

CHU de Caen

Caen, Cedex 9, 14033

Site Contact

[email protected]

650-542-0136

Chu Angers, Angers, France

Status

Recruiting

Address

Chu Angers

Angers, , 49933

Site Contact

[email protected]

650-542-0136

Centre Hospitalier du Mans, Le Mans, France

Status

Recruiting

Address

Centre Hospitalier du Mans

Le Mans, , 72000

Site Contact

[email protected]

650-542-0136

Institut Paoli-Calmettes, Marseille, France

Status

Recruiting

Address

Institut Paoli-Calmettes

Marseille, , 13009

Site Contact

[email protected]

650-542-0136

CHU Saint Eloi, Montpellier, France

Status

Recruiting

Address

CHU Saint Eloi

Montpellier, , 34295

Site Contact

[email protected]

650-542-0136

Hopital Saint Louis, Paris, France

Status

Recruiting

Address

Hopital Saint Louis

Paris, ,

Site Contact

[email protected]

650-542-0136

CHU Tours - Hôpital Bretonneau, Tours, France

Status

Recruiting

Address

CHU Tours - Hôpital Bretonneau

Tours, ,

Site Contact

[email protected]

650-542-0136

Aachen, Germany

Status

Recruiting

Address

Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, , 52074

Site Contact

[email protected]

650-542-0136

Halle, Germany

Status

Recruiting

Address

Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie

Halle, , 6120

Site Contact

[email protected]

650-542-0136

Universitaetsklinikum Jena, Jena, Germany

Status

Recruiting

Address

Universitaetsklinikum Jena

Jena, ,

Site Contact

[email protected]

650-542-0136

Mainz, Germany

Status

Recruiting

Address

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik

Mainz, , 55131

Site Contact

[email protected]

650-542-0136

Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany

Status

Recruiting

Address

Stauferklinikum Schwäbisch Gmünd

Mutlangen, , 73557

Site Contact

[email protected]

650-542-0136

Shamir Medical Center ( Assaf Harofeh), Zerifin, Israel

Status

Recruiting

Address

Shamir Medical Center ( Assaf Harofeh)

Zerifin, , 7033001

Site Contact

[email protected]

650-542-0136

Bologna, Italy

Status

Recruiting

Address

Bologna University Hospital, Institute of Hematology

Bologna, , 340136

Site Contact

[email protected]

650-542-0136

Universita degli Studi di Catania, Catania, Italy

Status

Recruiting

Address

Universita degli Studi di Catania

Catania, , 95124

Site Contact

[email protected]

650-542-0136

University of Florence, Firenze, Italy

Status

Recruiting

Address

University of Florence

Firenze, , 50134

Site Contact

[email protected]

650-542-0136

Istituto Tumori della Romagna (IRST), Meldola, Italy

Status

Recruiting

Address

Istituto Tumori della Romagna (IRST)

Meldola, , 47014

Site Contact

[email protected]

650-542-0136

Varese, Italy

Status

Recruiting

Address

Ospedale di Circolo e Fondazione MacchiASST Sette Laghi

Varese, , 21100

Site Contact

[email protected]

650-542-0136

Kraków, Poland

Status

Recruiting

Address

Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie

Kraków, ,

Site Contact

[email protected]

650-542-0136

Opole, Poland

Status

Recruiting

Address

Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii

Opole, ,

Site Contact

[email protected]

650-542-0136

Barcelona, Spain

Status

Recruiting

Address

d'Hebron University Hospital in Barcelona

Barcelona, , 08035

Site Contact

[email protected]

650-542-0136

Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Germans Trias i Pujol

Barcelona, , 08916

Site Contact

[email protected]

650-542-0136

Las Palmas De Gran Canaria, Spain

Status

Recruiting

Address

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas De Gran Canaria, ,

Site Contact

[email protected]

650-542-0136

Hospital Virgen de la Victoria, Málaga, Spain

Status

Recruiting

Address

Hospital Virgen de la Victoria

Málaga, , 29010

Site Contact

[email protected]

650-542-0136

Hospital Universitario de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hospital Universitario de Salamanca

Salamanca, ,

Site Contact

[email protected]

650-542-0136

Hospital de Dia Quiron Zaragoza, Zaragoza, Spain

Status

Recruiting

Address

Hospital de Dia Quiron Zaragoza

Zaragoza, , 50012

Site Contact

[email protected]

650-542-0136

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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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