An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
Who is this study for? Patients with Myelofibrosis
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Innovative Clinical Research Institute
RECRUITING
Glendale
Innovative Clinical Research Institute
RECRUITING
Whittier
Ohio
Gabrail Cancer Center
RECRUITING
Canton
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Belarus
Republican Scientific Practical Center of Radiation Medicine and Human Ecology
RECRUITING
Belarus’
Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
RECRUITING
Minsk
Bulgaria
UMHAT Georgi Stranski
RECRUITING
Pleven
Medical Centre Hipokrat N
RECRUITING
Plovdiv
Military Medical Academy
RECRUITING
Sofia
Specialized Hospital for Active Treatment of Hematologic Diseases
RECRUITING
Sofia
UMHAT Sv. Ivan Rilski EAD
RECRUITING
Sofia
Georgia
JSC EVEX Hospitals
RECRUITING
Kutaisi
K.Eristavi National Center of Experimental and Clinical Surgery
RECRUITING
Tbilisi
LTD M.Zodelava Hematology Centre
RECRUITING
Tbilisi
Mexico
Centro de Investigacion Medica Aquascalientes (CIMA)
RECRUITING
Aguascalientes
Unidad de Investigacion CIMA SC
RECRUITING
Chihuahua City
Centro de Investigacion Clinica de Oaxaca (CICLO)
RECRUITING
Oaxaca City
Sociedad de Metabolismo Y Corazon - SOMECO
RECRUITING
Veracruz
Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
RECRUITING
Katowice
Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej
RECRUITING
Opole
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
RECRUITING
Słupsk
Russian Federation
Botkin City Clinical Hospital
RECRUITING
Moscow
Republican Hospital n.a. V.A. Baranov
RECRUITING
Petrozavodsk
Almazov National Medical Research Center
RECRUITING
Saint Petersburg
Almazov National Medical Research Centre
RECRUITING
Saint Petersburg
Pavlov First Saint Petersburg State Medical University
RECRUITING
Saint Petersburg
Samara State Medical University
RECRUITING
Samara
South Africa
Wits Baragwanath Clinical Hematology Department
RECRUITING
Soweto
Ukraine
City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council
RECRUITING
Dnipro
Contact Information
Primary
John Mei
jmei@kartosthera.com
650-542-0136
Backup
Jordan Blevins
jblevins@kartosthera.com
650-542-0136
Time Frame
Start Date: 2021-04-13
Estimated Completion Date: 2025-10
Participants
Target number of participants: 52
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Kartos Therapeutics, Inc.