A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)
NCT ID: NCT04817007
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
216 participants
INTERVENTIONAL
2021-03-22
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A: BMS-986158 + Ruxolitinib
BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Part 1B: BMS-986158 + Fedratinib
BMS-986158
Specified dose on specified days
Fedratinib
Specified dose on specified days
Part 2A1: BMS-986158 + Ruxolitinib
BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Part 2B1: BMS-986158 + Fedratinib
BMS-986158
Specified dose on specified days
Fedratinib
Specified dose on specified days
Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable
BMS-986158
Specified dose on specified days
Fedratinib
Specified dose on specified days
Part 2A2 Add-On: BMS-986158 + Ruxolitinib
BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Part 2A3: BMS-986158 + Ruxolitinib
BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Interventions
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BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Fedratinib
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment
* Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
* Any significant acute or uncontrolled chronic medical illness
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0069
Newport Beach, California, United States
Local Institution - 0090
Lake Mary, Florida, United States
Local Institution - 0043
New Orleans, Louisiana, United States
Local Institution - 0038
Worcester, Massachusetts, United States
Local Institution - 0033
Ann Arbor, Michigan, United States
Local Institution - 0045
Hackensack, New Jersey, United States
Local Institution - 0076
Chapel Hill, North Carolina, United States
Local Institution - 0042
Pittsburgh, Pennsylvania, United States
Local Institution - 0036
Blacktown, New South Wales, Australia
Local Institution - 0032
Wollongong, New South Wales, Australia
Local Institution - 0007
East Melbourne, Victoria, Australia
Local Institution - 0006
Heidelberg, Victoria, Australia
Local Institution - 0041
Nedlands, Western Australia, Australia
Local Institution - 0015
West Perth, Western Australia, Australia
Local Institution - 0030
Brest, , France
Local Institution - 0008
Marseille, , France
Local Institution - 0027
Nice, , France
Local Institution - 0011
Paris, , France
Local Institution - 0010
Villejuif, , France
Local Institution - 0068
Erding, Bavaria, Germany
Local Institution - 0039
Essen, North Rhine-Westphalia, Germany
Local Institution - 0040
Chemnitz, Saxony, Germany
Local Institution - 0035
Halle, Saxony-Anhalt, Germany
Local Institution - 0050
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0061
Chaïdári, Attikí, Greece
Local Institution - 0047
Thessaloniki, Thessaloníki, Greece
Local Institution - 0073
Szeged, Csongrád megye, Hungary
Local Institution - 0072
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Local Institution - 0075
Budapest, , Hungary
Local Institution - 0074
Debrecen, , Hungary
Local Institution - 0086
Beersheba, Southern District, Israel
Local Institution - 0016
Jerusalem, , Israel
Local Institution - 0018
Petah Tikva, , Israel
Local Institution - 0017
Ramat Gan, , Israel
Local Institution - 0019
Tel Aviv, , Israel
Local Institution - 0003
Bologna, , Italy
Local Institution - 0002
Brescia, , Italy
Local Institution - 0001
Florence, , Italy
Local Institution - 0012
Verona, , Italy
Local Institution - 0077
Słupsk, Pomeranian Voivodeship, Poland
Local Institution - 0062
Gdansk, , Poland
Local Institution - 0052
Bucuresti, Cluj, Romania
Local Institution - 0083
Bucharest, , Romania
Local Institution - 0051
Cluj-Napoca, , Romania
Local Institution - 0049
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0048
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0053
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0020
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0029
Santander, Cantabria, Spain
Local Institution - 0054
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0026
Madrid, , Spain
Local Institution - 0021
Salamanca, , Spain
Local Institution - 0094
Valencia, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-002071-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA011-023
Identifier Type: -
Identifier Source: org_study_id
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