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A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BMS-911543 in Subjects With Myelofibrosis


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BMS-911543 in Subjects With Myelofibrosis


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

- 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
Immunodeficiency Virus-1 (HIV-1), or HIV-2 antibodies

- Abnormalities in serum electrolytes

- Significant cardiovascular disease

- Current or recent gastrointestinal disease

- Evidence of uncontrolled active infection or active graft vs. host disease

- Inability to tolerate oral medication

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety assessed by medical review of adverse events and results of vital signs, Electrocardiograms (ECGs), physical examinations, and lab tests and evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

Outcome Time Frame:

Day 1 of each Cycle

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

CA215-001

NCT ID:

NCT01236352

Start Date:

May 2011

Completion Date:

May 2013

Related Keywords:

  • Cancer
  • Advanced Cancer, Various, NOS

Name

Location

Mayo ClinicRochester, Minnesota  55905
Local InstitutionBronx, New York  
University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030