Multiple Ascending Dose of BMS-911543

NCT ID: NCT01236352

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-07
• Study Completion Date: 2015-11-19

Brief 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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 (Cohort 1): BMS-911543 (5 mg)

BMS-911543 5 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 2): BMS-911543 (10 mg)

BMS-911543 10 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 3): BMS-911543 (20 mg)

BMS-911543 20 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 4): BMS-911543 (40 mg)

BMS-911543 40 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 5): BMS-911543 (80 mg)

BMS-911543 80 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 6): BMS-911543 (120 mg)

BMS-911543 120 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 7): BMS-911543 (160 mg)

BMS-911543 160 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 8): BMS-911543 (200 mg)

BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 9): BMS-911543 (240 mg)

BMS-911543 240 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 1 (Cohort 10): BMS-911543 (320 mg)

BMS-911543 320 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 2 (Cohort 11): BMS-911543 (120 mg)

BMS-911543 120 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Phase 2 (Cohort 12): BMS-911543 (200 mg)

BMS-911543 200 mg capsule by mouth twice daily for 12 months or greater depending on response

Group Type: EXPERIMENTAL

BMS-911543

Intervention Type: DRUG

Interventions

BMS-911543

Intervention Type: DRUG

Other Intervention Names

JAK2 Inhibitor

Eligibility Criteria

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 Immunodeficiency Virus-1 (HIV-1), or HIV-2 antibodies
• Abnormalities in serum electrolytes
• Significant cardiovascular disease
• Current or recent gastrointestinal disease
• Previous history of pancreatitis and/or significant risk factors for pancreatitis as judged by the treating physician
• Evidence of uncontrolled active infection or active graft vs. host disease
• Inability to tolerate oral medication

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Mayo Clinic

Rochester, Minnesota, United States

The Mount Sinai School Of Medicine

New York, New York, United States

The University Of Texas Md Anderson Cancer Center

Houston, Texas, United States

Local Institution

East Melbourne, Victoria, Australia

Local Institution

Melbourne, Victoria, Australia

Countries

United States; Australia

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

Other Identifiers

CA215-001

Identifier Type: -

Identifier Source: org_study_id