Myelodysplastic Syndrome Clinical Trial

A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis

Summary

Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis.

Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis.

CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Phase 2 part: Patients with confirmed diagnosis of MF who meet all of the following criteria:

ANC ≥ 1 x 10^9/L without the assistance of granulocyte growth factors
Peripheral blood blast count <10%
ECOG performance status ≤ 2.
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
No prior treatment with a BET inhibitor
Patients must give written informed consent to participate in this study before the performance of any study-related procedure.

For Arm 1 and 2 the following criteria should be considered:

Patients with confirmed diagnosis of MF who meet all of the following criteria
Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-2 or higher
Spleen volume ≥ 450 cm^3 by MRI or CT for Cohorts 1B and 2B OR RBC transfusion dependent (defined as an average of ≥2 units of RBC transfusions per month (total of greater than 6 RBC transfusions) over the 12 weeks prior to enrollment for Cohorts 1A and 2A)
At least 2 symptoms measurable (Score ≥ 1) using the Myelofibrosis Symptom Assessment Form Version 4.0 (MFSAF v4.0)
Platelet count ≥ 75 x 10^9/L without the assistance of thrombopoietic factors or transfusions for at least 14 days
Arm (Arm 1): Previously treated with a JAK inhibitor and be intolerant, resistant, refractory, or lost response to the JAK inhibitor; have not received the JAK inhibitor within 2 weeks prior to the start of study drug, or are ineligible to be treated with a JAK inhibitor
Combination Arm (Arm 2): Must have received single agent ruxolitinib and be on a stable dose for a minimum 8 weeks but have disease that is not being adequately controlled by ruxolitinib

For Arm 3 (JAK inhibitors naïve) the following criteria should be considered:

Patients with confirmed diagnosis of MF who meet all of the following criteria
Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-2 or higher
Platelet count ≥ 100 x 10^9/L without the assistance of thrombopoietic factors or transfusions
Spleen volume ≥ 450 cm^3 by MRI/CT
At least 2 symptoms measurable (Score ≥ 3) or a total score of ≥ 10 using the Myelofibrosis Symptom Assessment Form Version 4.0 ( MFSAF v4.0)
No prior treatment with JAKi allowed

For Arm 4 (ET Expansion) the following criteria should be considered:

Patients with a confirmed diagnosis of ET
High-risk disease, defined as meeting at least one of the following criteria:
Age > 60 years
Platelet count > 1500 × 10^9/L (at any point during the patient's disease)
Previously documented thrombosis, erythromelalgia, or migraine
Previous hemorrhage related to ET
Diabetes or hypertension requiring pharmacological therapy for > 6 months

Have ≥2 symptoms with an average score ≥ 3 over the 7-day period prior to Cycle 1 Day 1 or an average total score of ≥15 over the 7-day period prior to Cycle 1 Day 1 using the using the MPN SAF

Platelets > 600 × 10^9/L
Resistant or intolerant to HU

Exclusion Criteria:

Current known active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
Impaired cardiac function or clinically significant cardiac diseases
Patients with Child-Pugh Class B or C
Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of pelabresib and/or ruxolitinib, including any unresolved nausea, vomiting, or diarrhea that is CTCAE Grade >1
Prior treatment with a BET inhibitor.
Pregnant or lactating women
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study
Patients unwilling or unable to comply with this study protocol.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

341

Study ID:

NCT02158858

Recruitment Status:

Active, not recruiting

Sponsor:

Constellation Pharmaceuticals

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There are 48 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Northwestern University - Lurie Comprehensive Cancer Center
Chicago Illinois, 60611, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Washington University School of Medicne Neuromuscular Division Department of Neurology Research
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
ICAHN School of Medicine at Mount Sinai
New York New York, 10029, United States
Weill Medical College and New York Presbyterian Hospital
New York New York, 10065, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Froedtert & Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
UZ Leuven - Campus Gasthuisberg
Leuven Viaams Braban, 3000, Belgium
AZ Sint-Jan Burgge-Oostende AV- Campus Sint-Jan
Brugge West-Vlaanderen, 8000, Belgium
ZNA Stuyvenberg Antwerpen
Antwerpen , 2060, Belgium
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
St. Paul's Hospital
Vancouver British Columbia, V6Z 2, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Institut de cancérologie du Gard - Hematologie clinique
Nîmes Gard, 30029, France
CHRU de Lille - Hopital Claude Huriez
Toulouse Haute-Garonne, 31059, France
Institut Gustave Roussy
Villejuif Ile-de-France, 94805, France
CHRU de Lille - Hopital Claude Huriez - Maladies du Sang
Lille Nord-Pas-de-Calais, 59037, France
CHU - Hopital Saint Louis - Centre D'Investigations Clinique
Paris , 75010, France
Universitätsklinikum Bonn
Bonn Nordrhein-Westfalen, 53127, Germany
Universitätsklinikum Leipzig AöR
Leipzig Sachsen, 04103, Germany
Institue of Hematology "L. and A. Seràgnoli"
Bologna Emilia-Romagna, 40138, Italy
Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale (AUSL) di Rimini - Ospedale Infermi di Rimini
Rimini Emilia-Romagna, 47923, Italy
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
Genova Liguria, 16132, Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milano Lombardia, 20122, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia Lombardia, 27100, Italy
Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon
Varese Lombardia, 21100, Italy
Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy
AOU Maggiore della Carità
Novara , 28100, Italy
Maastricht University Medical Center
Maastricht Limburg, 6229 , Netherlands
VUmcResearch B.V.
Amsterdam Noord-Holland, 1081 , Netherlands
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam Zuid-Holland, 3015 , Netherlands
Instytut Hematologii i Transfuzjologii w Warszawie
Warszawa Mazowieckie, 02-77, Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk Pomorskie, 80-95, Poland
Oxford University Hospitals
Headington Oxford, OX3 7, United Kingdom
Belfast City Hospital
Belfast , BT9 7, United Kingdom
University of Cambridge
Cambridge , CB2 0, United Kingdom
University Hospital of Wales
Cardiff , CF14 , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
University College London Hospital's NHS foundation Trust
London , NW1 2, United Kingdom
Guys and St Thomas' Hospital - Haematology
London , SE1 9, United Kingdom
The Christie Hospital
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

341

Study ID:

NCT02158858

Recruitment Status:

Active, not recruiting

Sponsor:


Constellation Pharmaceuticals

How clear is this clinincal trial information?

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