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Active (not recruiting) Phase 1/2 NCT04817007

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)

Phase 1/2 – combined early trial
Conditions: Myelofibrosis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 12
Australia (1)
Local Institution - 0036
Blacktown , New South Wales
France (1)
Local Institution - 0030
Brest
Germany (1)
Local Institution - 0068
Erding , Bavaria
Greece (1)
Local Institution - 0061
Chaïdári , Attikí
Hungary (1)
Local Institution - 0073
Szeged , Csongrád megye
Israel (1)
Local Institution - 0086
Beersheba , Southern District
Italy (1)
Local Institution - 0003
Bologna
Poland (1)
Local Institution - 0077
Słupsk , Pomeranian Voivodeship
Romania (1)
Local Institution - 0052
Bucuresti , Cluj
South Korea (1)
Local Institution - 0049
Seongnam , Kyǒnggi-do
Spain (1)
Local Institution - 0020
Badalona , Barcelona [Barcelona]
United States (1)
Local Institution - 0069
Newport Beach , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.03.2021
Completion date
31.05.2026
Registry ID
NCT04817007
Source
anzctr
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