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Clinical Trial Finder

Search Results

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Study Purpose

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

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:

  • - 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.

Exclusion Criteria:

  • - 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.
- Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

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.

NCT04878003
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.

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 Belarus, Bulgaria, Georgia, Mexico, Poland, Russian Federation, South Africa, Ukraine, United States
Conditions

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)
Arms & Interventions

Arms

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

Interventions

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.

Innovative Clinical Research Institute, Glendale, California

Status

Recruiting

Address

Innovative Clinical Research Institute

Glendale, California, 90603

Site Contact

[email protected]

650-542-0136

Innovative Clinical Research Institute, Whittier, California

Status

Recruiting

Address

Innovative Clinical Research Institute

Whittier, California, 90603

Site Contact

[email protected]

650-542-0136

Gabrail Cancer Center, Canton, Ohio

Status

Recruiting

Address

Gabrail Cancer Center

Canton, Ohio, 44718

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

International Sites

Belarus, Belarus

Status

Recruiting

Address

Republican Scientific Practical Center of Radiation Medicine and Human Ecology

Belarus, , 246040

Site Contact

[email protected]

650-542-0136

Minsk, Belarus

Status

Recruiting

Address

Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology

Minsk, , 220045

Site Contact

[email protected]

650-542-0136

UMHAT Georgi Stranski, Pleven, Bulgaria

Status

Recruiting

Address

UMHAT Georgi Stranski

Pleven, , 5800

Site Contact

[email protected]

650-542-0136

Medical Centre Hipokrat N, Plovdiv, Bulgaria

Status

Recruiting

Address

Medical Centre Hipokrat N

Plovdiv, , 4000

Site Contact

[email protected]

650-542-0136

UMHAT Sv. Ivan Rilski EAD, Sofia, Bulgaria

Status

Recruiting

Address

UMHAT Sv. Ivan Rilski EAD

Sofia, , 1431

Site Contact

[email protected]

650-542-0136

Military Medical Academy, Sofia, Bulgaria

Status

Recruiting

Address

Military Medical Academy

Sofia, , 1606

Site Contact

[email protected]

650-542-0136

Sofia, Bulgaria

Status

Recruiting

Address

Specialized Hospital for Active Treatment of Hematologic Diseases

Sofia, , 1756

Site Contact

[email protected]

650-542-0136

JSC EVEX Hospitals, Kutaisi, Georgia

Status

Recruiting

Address

JSC EVEX Hospitals

Kutaisi, , 4600

Site Contact

[email protected]

650-542-0136

LTD M.Zodelava Hematology Centre, Tbilisi, Georgia

Status

Recruiting

Address

LTD M.Zodelava Hematology Centre

Tbilisi, , 112

Site Contact

[email protected]

650-542-0136

Tbilisi, Georgia

Status

Recruiting

Address

K.Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, , 159

Site Contact

[email protected]

650-542-0136

Aguascalientes, Mexico

Status

Recruiting

Address

Centro de Investigacion Medica Aquascalientes (CIMA)

Aguascalientes, , 20116

Site Contact

[email protected]

650-542-0136

Unidad de Investigacion CIMA SC, Chihuahua, Mexico

Status

Recruiting

Address

Unidad de Investigacion CIMA SC

Chihuahua, , 31200

Site Contact

[email protected]

650-542-0136

Oaxaca, Mexico

Status

Recruiting

Address

Centro de Investigacion Clinica de Oaxaca (CICLO)

Oaxaca, , 68020

Site Contact

[email protected]

650-542-0136

Veracruz, Mexico

Status

Recruiting

Address

Sociedad de Metabolismo Y Corazon - SOMECO

Veracruz, , 91900

Site Contact

[email protected]

650-542-0136

Katowice, Poland

Status

Recruiting

Address

Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich

Katowice, , 40-519

Site Contact

[email protected]

650-542-0136

Opole, Poland

Status

Recruiting

Address

Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej

Opole, , 45-061

Site Contact

[email protected]

650-542-0136

Słupsk, Poland

Status

Recruiting

Address

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

Słupsk, , 76-200

Site Contact

[email protected]

650-542-0136

Botkin City Clinical Hospital, Moscow, Russian Federation

Status

Recruiting

Address

Botkin City Clinical Hospital

Moscow, , 125284

Site Contact

[email protected]

650-542-0136

Republican Hospital n.a. V.A. Baranov, Petrozavodsk, Russian Federation

Status

Recruiting

Address

Republican Hospital n.a. V.A. Baranov

Petrozavodsk, , 185019

Site Contact

[email protected]

650-542-0136

Saint Petersburg, Russian Federation

Status

Recruiting

Address

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , 197022

Site Contact

[email protected]

650-542-0136

Almazov National Medical Research Center, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Almazov National Medical Research Center

Saint Petersburg, , 197341

Site Contact

[email protected]

650-542-0136

Almazov National Medical Research Centre, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Almazov National Medical Research Centre

Saint Petersburg, , 197341

Site Contact

[email protected]

650-542-0136

Samara State Medical University, Samara, Russian Federation

Status

Recruiting

Address

Samara State Medical University

Samara, , 443099

Site Contact

[email protected]

650-542-0136

Soweto, South Africa

Status

Recruiting

Address

Wits Baragwanath Clinical Hematology Department

Soweto, , 1519

Site Contact

[email protected]

650-542-0136

Dnipro, Ukraine

Status

Recruiting

Address

City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council

Dnipro, , 49102

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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