TerminatedPhase 1/2

Multiple Ascending Dose of BMS-911543

Stopped: Due to portfolio/business decisions by the sponsor

United States, Australia98 participantsStarted 2011-04-07

Plain-language summary

The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Men and Women at least 18 years old * A diagnosis of symptomatic, primary or secondary Myelofibrosis (MF) \[World Health Organization (WHO) 2008 criteria\] with intermediate-1, intermediate-2 or high risk disease as assessed using the Dynamic International Prognostic Scoring System international prognostic scoring system * Last therapeutic or diagnostic treatment at least 28 days prior * Any toxicity from prior therapies must have resolved to Grade ≤1 * Adequate Liver and Kidney Function * Serum amylase and lipase within normal institutional range * Platelet count ≥50,000 cell mm³ * Absolute neutrophil count (ANC) ≥1,000 cells/mm3 * Hemoglobin ≥8.0 g/dL Exclusion Criteria: * Primary central nervous system tumors * Subjects with currently active malignancy (other than MF) or with a prior history of malignancy with the exception of: (i) adequately treated basal cell carcinoma of the skin, (ii) curatively treated in situ carcinoma of the cervix, (iii) other malignancy that has undergone potentially curative therapy with no evidence of disease recurrence ≥3 years * Any condition requiring chronic use of moderate/high dose steroids except inhalation or oral steroids for mild pulmonary disease * Splenic irradiation ≤3 months prior to treatment with study drug * Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or Human Immunodefi…

What they're measuring

Number of Participants With Adverse Events

Timeframe: From the date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occured at a later time, assessed up to 4.5 years

Number of Participants With Best Overall Response

Timeframe: Day 1, at each returning on-treatment visit and the first post-treatment visit

Trial details

NCT IDNCT01236352

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11-19

Results submitted2019-03-21

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