A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
Who is this study for? Patients with relapsed/refractory myelofibrosis, Janus Kinase Inhibitor intolerant myelofibrosis and Janus Kinase Inhibitor treatment ineligible myelofibrosis
What treatments are being studied? TL-895
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults ≥18 years of age
• Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
• Adequate hematologic, hepatic, and renal functions
• MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
• Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and \< 50 x 10\^9/L
• Adults ≥18 years of age
• Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
• Subject must have moderate-to-severe symptoms
Locations
United States
Colorado
University of Colorado - Aurora Cancer Center
COMPLETED
Aurora
Minnesota
Mayo Clinic - Rochester
RECRUITING
Rochester
Ohio
Gabrail Cancer Center
COMPLETED
Canton
University of Cincinnati (UC) Physicians Company, LLC
ACTIVE_NOT_RECRUITING
Cincinnati
Ohio State University
ACTIVE_NOT_RECRUITING
Columbus
Texas
University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Australia
Border Medical Oncology
COMPLETED
East Albury
Southern Oncology Specialists
COMPLETED
Kogarah
Royal Perth Hospital
RECRUITING
Perth
St Vincent's Hospital Sydney
RECRUITING
Sydney
Belgium
Chu De Liège
RECRUITING
Liège
Cliniques Universitaires Saint-Luc
ACTIVE_NOT_RECRUITING
Woluwe-saint-lambert
Brazil
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
COMPLETED
São Paulo
Bulgaria
Military Medical Academy
ACTIVE_NOT_RECRUITING
Sofia
University Hospital St Ivan Rilski
COMPLETED
Sofia
France
CH Le Mans
ACTIVE_NOT_RECRUITING
Le Mans
CHU de Nantes - Hôtel-Dieu
COMPLETED
Nantes
CHU de Nice - Hopital L' Archet II
COMPLETED
Nice
Germany
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Marien Hospital Duesseldorf
COMPLETED
Düsseldorf
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
RECRUITING
Halle
Universitaetsklinikum Jena
RECRUITING
Jena
Praxisklinik fur Hamatologie und Onkologie
COMPLETED
Koblenz
Hungary
Debreceni Egyetem Klinikai Kozpont
COMPLETED
Debrecen
Markhot Ferenc Oktatokorhaz es Rendelointezet
COMPLETED
Eger
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
COMPLETED
Nyíregyháza
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
COMPLETED
Székesfehérvár
Italy
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
ACTIVE_NOT_RECRUITING
Catania
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
ACTIVE_NOT_RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
ACTIVE_NOT_RECRUITING
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliero Universitaria Maggiore Della Carita'
ACTIVE_NOT_RECRUITING
Novara
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
ACTIVE_NOT_RECRUITING
Perugia
AUSL della Romagna-Ospedale S.Maria delle Croci
ACTIVE_NOT_RECRUITING
Ravenna
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
ACTIVE_NOT_RECRUITING
Reggio Calabria
Azienda Ospedaliero Universitaria Policlinico Umberto I
ACTIVE_NOT_RECRUITING
Roma
Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
ACTIVE_NOT_RECRUITING
Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
ACTIVE_NOT_RECRUITING
Gdansk
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
NOT_YET_RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
RECRUITING
Wroclaw
Republic of Korea
Kyungpook National University Hospital
COMPLETED
Daegu
Seoul National University Hospital
COMPLETED
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
COMPLETED
Seoul
Spain
Hospital Germans Trias i Pujol
RECRUITING
Barcelona
Institut Catala d'Oncologia - L'Hospitalet
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Salamanca University Hospital
COMPLETED
Salamanca
Hospital Quirónsalud Zaragoza
RECRUITING
Zaragoza
Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
COMPLETED
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
ACTIVE_NOT_RECRUITING
Kaohsiung City
China Medical University Hospital
COMPLETED
Taichung
National Taiwan University Hospital
COMPLETED
Taipei
Contact Information
Primary
John Mei
jmei@teliospharma.com
650-542-0136
Backup
Emily Houlihan
ehoulihan@teliospharma.com
401-954-8042
Time Frame
Start Date: 2020-10-22
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 121
Treatments
Experimental: Cohort 1a, Relapsed/Refractory Myelofibrosis
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 1b, Relapsed/Refractory Myelofibrosis
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 1c, Relapsed/Refractory Myelofibrosis
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 1d, Relapsed/Refractory Myelofibrosis
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 2a, JAKi Intolerant Myelofibrosis
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 2b, JAKi Intolerant Myelofibrosis
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L
300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.
Experimental: Cohort 5a, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with best supportive care (BSC).
Experimental: Cohort 5b, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
Experimental: Cohort 5c, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
Experimental: Cohort 5d, Indolent Systemic Mastocytosis
TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
Placebo_comparator: Cohort 5e, Indolent Systemic Mastocytosis
Placebo to match TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.
Authors
Related Therapeutic Areas
Sponsors
Leads: Telios Pharma, Inc.