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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04817007
Other study ID # CA011-023
Secondary ID 2020-002071-35
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 22, 2021
Est. completion date May 31, 2026

Study information

Verified date May 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 216
Est. completion date May 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986158
Specified dose on specified days
Ruxolitinib
Specified dose on specified days
Fedratinib
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0036 Blacktown 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 - 0032 Wollongong New South Wales
France Local Institution - 0030 Brest
France Local Institution - 0008 Marseille
France Local Institution - 0027 Nice
France Local Institution - 0011 Paris
France Local Institution - 0010 Villejuif
Germany Local Institution - 0040 Chemnitz Sachsen
Germany Local Institution - 0068 Erding
Germany Local Institution - 0039 Essen Nordrhein-Westfalen
Germany Local Institution - 0035 Halle Sachsen-Anhalt
Germany Local Institution - 0050 Lübeck Schleswig-Holstein
Greece Local Institution - 0061 Chaidari Attikí
Greece Local Institution - 0047 Thessaloniki Thessaloníki
Hungary Local Institution - 0075 Budapest
Hungary Local Institution - 0074 Debrecen
Hungary Local Institution - 0072 Nyiregyhaza Szabolcs-Szatmár-Bereg
Hungary Local Institution - 0073 Szeged Csongrád
Israel Local Institution - 0086 Be'er Sheva HaDarom
Israel Local Institution - 0016 Jerusalem
Israel Local Institution - 0018 Petah-Tikva
Israel Local Institution - 0017 Ramat Gan
Israel Local Institution - 0019 Tel Aviv
Italy Local Institution - 0003 Bologna
Italy Local Institution - 0002 Brescia
Italy Local Institution - 0001 Firenze
Italy Local Institution - 0012 Verona
Korea, Republic of Local Institution - 0049 Seongnam Kyonggi-do
Korea, Republic of Local Institution - 0048 Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Local Institution - 0053 Seoul Seoul-teukbyeolsi [Seoul]
Poland Local Institution - 0062 Gdansk
Poland Local Institution - 0077 Slupsk Pomorskie
Romania Local Institution - 0052 Bucuresti Cluj
Romania Local Institution - 0083 Bucuresti
Romania Local Institution - 0051 Cluj
Spain Local Institution - 0020 Badalona Barcelona [Barcelona]
Spain Local Institution - 0026 Madrid
Spain Local Institution - 0054 Madrid Madrid, Comunidad De
Spain Local Institution - 0021 Salamanca
Spain Local Institution - 0029 Santander
Spain Local Institution - 0094 València
United States Local Institution - 0033 Ann Arbor Michigan
United States Local Institution - 0076 Chapel Hill North Carolina
United States Local Institution - 0045 Hackensack New Jersey
United States Local Institution - 0090 Lake Mary Florida
United States Local Institution - 0043 New Orleans Louisiana
United States Local Institution - 0069 Newport Beach California
United States Local Institution - 0042 Pittsburgh Pennsylvania
United States Local Institution - 0038 Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Romania,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) Up to 52 months
Primary Incidence of serious adverse events (SAEs) Up to 52 months
Primary Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria Up to 26 months
Primary Incidence of AEs leading to discontinuation Up to 52 months
Primary Incidence of death Up to 52 months
Secondary Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR) Up to 175 days
Secondary 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 Up to 175 days
Secondary SVR at end of Cycle 3 and 6 assessed by BICR Up to 175 days
Secondary 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 Up to 175 days
Secondary Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF) Up to 175 days
Secondary Additional measures based on TSS measured by MFSAF Up to 175 days
Secondary For transfusion independent (TI), proportion of participants having = 2.0 g/dL hemoglobin (Hgb) increase over baseline Up to 24 months
Secondary 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 Up to 24 months
Secondary 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 Up to 24 months
Secondary For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of hydroxyurea over any consecutive 12-week period Up to 24 months
Secondary Summary of plasma concentrations pharmacokinetics (PK) parameters: maximum observed concentration (Cmax) Up to 56 days
Secondary Summary of plasma concentrations PK parameters: time of maximum observed concentration (Tmax) Up to 56 days
Secondary 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)) Up to 56 days
Secondary 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)
6 month and 12 month
Secondary 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 6 month and 12 month
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