Back to resultsA 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)
Primary Purpose
Myelofibrosis
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986158
Ruxolitinib
Fedratinib
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis focused on measuring BMS-986158, Fedratinib, Myelofibrosis, Ruxolitinib
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
- 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:
- Women who are pregnant or breastfeeding at screening
- Any significant acute or uncontrolled chronic medical illness
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Moores Cancer Center-Clinical Trials Office - Hematology
- Hoag Memorial Hospital Presbyterian
- Florida Cancer Specialists Lake Mary Drug Development Unit
- Tulane Cancer CenterRecruiting
- Tufts Medical Center
- Massachusetts General Hospital
- University of Massachusetts Medical School-Division of Hematology/OncologyRecruiting
- University Of MichiganRecruiting
- John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
- Icahn School of Medicine at Mount Sinai
- University of North Carolina Medical Center
- Levine Cancer Institute
- AHN West Penn HospitalRecruiting
- Lifespan Cancer Institute
- Medical University of South Carolina
- Mays Cancer Center
- Local Institution - 0036Recruiting
- Local Institution - 0032Recruiting
- Local Institution - 0007Recruiting
- Local Institution - 0006Recruiting
- Local Institution - 0041Recruiting
- Local Institution - 0015Recruiting
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan-Institut de cancérologie et hémaRecruiting
- Institut Paoli-Calmettes-HematologyRecruiting
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-HematologyRecruiting
- Hôpital Saint-Louis-Centre d'Investigations CliniquesRecruiting
- Gustave Roussy-DITEPRecruiting
- Local Institution - 0039Recruiting
- Local Institution - 0035Recruiting
- Local Institution - 0040Recruiting
- Local Institution - 0050
- Local Institution - 0068Recruiting
- Local Institution - 0061Recruiting
- Local Institution - 0047
- Local Institution - 0086
- Local Institution - 0016Recruiting
- Local Institution - 0018Recruiting
- Local Institution - 0017Recruiting
- Local Institution - 0019Recruiting
- Local Institution - 0003
- Local Institution - 0002Recruiting
- Local Institution - 0001Recruiting
- Local Institution - 0012Recruiting
- Local Institution - 0049
- Local Institution - 0048
- Local Institution - 0053
- Local Institution - 0063
- Local Institution - 0062Recruiting
- Local Institution - 0077
- Local Institution - 0052Recruiting
- Local Institution - 0083Recruiting
- Local Institution - 0051Recruiting
- Local Institution - 0020Recruiting
- Local Institution - 0054Recruiting
- Local Institution - 0026Recruiting
- Local Institution - 0021Recruiting
- Local Institution - 0029Recruiting
- Local Institution - 0094
- Local Institution - 0088
- Local Institution - 0079
- Local Institution - 0080
- Local Institution - 0089
- Local Institution - 0081
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1A: BMS-986158 + Ruxolitinib
Part 1B: BMS-986158 + Fedratinib
Part 2A1: BMS-986158 + Ruxolitinib
Part 2B1: BMS-986158 + Fedratinib
Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable
Part 2A2 Add-On: BMS-986158 + Ruxolitinib
Part 2A3: BMS-986158 + Ruxolitinib
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Incidence of AEs leading to discontinuation
Incidence of death
Secondary Outcome Measures
Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR)
Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
SVR at end of Cycle 3 and 6 assessed by BICR
Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Additional measures based on TSS measured by MFSAF
For transfusion independent (TI), proportion of participants having ≥ 2.0 g/dL hemoglobin (Hgb) increase over baseline
For transfusion dependent (TD), proportion of participants becoming TI as measured by the absence of red blood cell (RBC) transfusions over any consecutive 12-week period
For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of erythropoiesis stimulating agents (ESA) over any consecutive 12-week period
For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of hydroxyurea over any consecutive 12-week period
Summary of plasma concentrations pharmacokinetics (PK) parameters: maximum observed concentration (Cmax)
Summary of plasma concentrations PK parameters: time of maximum observed concentration (Tmax)
Summary of plasma concentrations PK parameters: area under the concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC (0-T))
Time from Dose 1, Day 1 to death due to any reason or disease progression (per modified IWG-MRT 2013) assessed by BICR: SDPFS rates at 6 months and 12 months
International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Spleen and disease progression free survival (SDPFS)
Time from Dose 1, Day 1 to death due to any reason or disease progression (per modified IWG-MRT 2013) assessed by BICR: median SDPFS at 6 months and 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04817007
Brief Title
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)
Official Title
A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
April 14, 2025 (Anticipated)
Study Completion Date
April 26, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
Keywords
BMS-986158, Fedratinib, Myelofibrosis, Ruxolitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1A: BMS-986158 + Ruxolitinib
Arm Type
Experimental
Arm Title
Part 1B: BMS-986158 + Fedratinib
Arm Type
Experimental
Arm Title
Part 2A1: BMS-986158 + Ruxolitinib
Arm Type
Experimental
Arm Title
Part 2B1: BMS-986158 + Fedratinib
Arm Type
Experimental
Arm Title
Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable
Arm Type
Experimental
Arm Title
Part 2A2 Add-On: BMS-986158 + Ruxolitinib
Arm Type
Experimental
Arm Title
Part 2A3: BMS-986158 + Ruxolitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986158
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
Jakafi®
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Fedratinib
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to 52 months
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 52 months
Title
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame
Up to 26 months
Title
Incidence of AEs leading to discontinuation
Time Frame
Up to 52 months
Title
Incidence of death
Time Frame
Up to 52 months
Secondary Outcome Measure Information:
Title
Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR)
Time Frame
Up to 175 days
Title
Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Time Frame
Up to 175 days
Title
SVR at end of Cycle 3 and 6 assessed by BICR
Time Frame
Up to 175 days
Title
Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Time Frame
Up to 175 days
Title
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Time Frame
Up to 175 days
Title
Additional measures based on TSS measured by MFSAF
Time Frame
Up to 175 days
Title
For transfusion independent (TI), proportion of participants having ≥ 2.0 g/dL hemoglobin (Hgb) increase over baseline
Time Frame
Up to 24 months
Title
For transfusion dependent (TD), proportion of participants becoming TI as measured by the absence of red blood cell (RBC) transfusions over any consecutive 12-week period
Time Frame
Up to 24 months
Title
For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of erythropoiesis stimulating agents (ESA) over any consecutive 12-week period
Time Frame
Up to 24 months
Title
For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of hydroxyurea over any consecutive 12-week period
Time Frame
Up to 24 months
Title
Summary of plasma concentrations pharmacokinetics (PK) parameters: maximum observed concentration (Cmax)
Time Frame
Up to 56 days
Title
Summary of plasma concentrations PK parameters: time of maximum observed concentration (Tmax)
Time Frame
Up to 56 days
Title
Summary of plasma concentrations PK parameters: area under the concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC (0-T))
Time Frame
Up to 56 days
Title
Time from Dose 1, Day 1 to death due to any reason or disease progression (per modified IWG-MRT 2013) assessed by BICR: SDPFS rates at 6 months and 12 months
Description
International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Spleen and disease progression free survival (SDPFS)
Time Frame
6 month and 12 month
Title
Time from Dose 1, Day 1 to death due to any reason or disease progression (per modified IWG-MRT 2013) assessed by BICR: median SDPFS at 6 months and 12 months
Time Frame
6 month and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
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:
Women who are pregnant or breastfeeding at screening
Any significant acute or uncontrolled chronic medical illness
Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Moores Cancer Center-Clinical Trials Office - Hematology
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Withdrawn
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pooja Motwani, Site 0069
Phone
501-425-4481
Facility Name
Florida Cancer Specialists Lake Mary Drug Development Unit
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Philipovskiy, Site 0090
Phone
407-804-6133
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hana Safah, Site 0043
Phone
504-988-6070
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Zhou, Site 0082
Phone
617-636-7742
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Hobbs, Site 0093
Phone
617-724-3456
Facility Name
University of Massachusetts Medical School-Division of Hematology/Oncology
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Gerber, Site 0038
Phone
508-635-7093
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Talpaz, Site 0033
Phone
734-647-9913
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James McCloskey, Site 0045
Phone
551-996-3925
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Mascarenhas, Site 0095
Phone
212-241-4106
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Reeves, Site 0076
Phone
919-966-5879
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksander Chojecki, Site 0078
Phone
980-442-4363
Facility Name
AHN West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salman Fazal, Site 0042
Phone
412-578-4355
Facility Name
Lifespan Cancer Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Reagan, Site 0071
Phone
401-444-5435
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Coltoff, Site 0087
Phone
631-487-7301
Facility Name
Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0036
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0032
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0007
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0006
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0041
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0041
Facility Name
Local Institution - 0015
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan-Institut de cancérologie et héma
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe IANOTTO, Site 0030
Phone
+33298223786
Facility Name
Institut Paoli-Calmettes-Hematology
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome Rey, Site 0008
Phone
33491223481
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Loschi, Site 0027
Phone
33492035841
Facility Name
Hôpital Saint-Louis-Centre d'Investigations Cliniques
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Kiladjian, Site 0011
Phone
0142499429
Facility Name
Gustave Roussy-DITEP
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Ribrag, Site 0010
Phone
33142114507
Facility Name
Local Institution - 0039
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0035
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0040
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0050
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0068
City
Erding
ZIP/Postal Code
85435
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0068
Facility Name
Local Institution - 0061
City
Chaidari
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Local Institution - 0047
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 10
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0086
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0086
Facility Name
Local Institution - 0016
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0018
City
Petah-Tikva
ZIP/Postal Code
4910021
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0017
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0019
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0003
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0002
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0002
Facility Name
Local Institution - 0001
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0012
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0049
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0048
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0053
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0063
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0063
Facility Name
Local Institution - 0062
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0062
Facility Name
Local Institution - 0077
City
Słupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0077
Facility Name
Local Institution - 0052
City
Bucuresti
State/Province
Cluj
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0083
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0083
Facility Name
Local Institution - 0051
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0020
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0054
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0026
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0021
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0029
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0094
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0094
Facility Name
Local Institution - 0088
City
Stanbul
State/Province
İstanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0088
Facility Name
Local Institution - 0079
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution - 0080
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0080
Facility Name
Local Institution - 0089
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0089
Facility Name
Local Institution - 0081
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0081
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
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)
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