Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

NCT01363817 | Completed Phase 1 FDA Drug

• 2 other identifiers: CA216-0022010-022727-29
• Study Type: interventional
• Target: 31
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies

Conditions

Lymphoblastic Leukemia, Acute T-cell; Precursor T-Cell Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events as a measure of safety and tolerability

  Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.

Secondary Outcomes (8)

• Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI)

  Disease assessments at least every 8 weeks during treatment

• Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax)

  Pharmacokinetics at multiple time points during the first 4 weeks of dosing

• Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin)

  Pharmacokinetics at multiple time points during the first 4 weeks of dosing

• Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: area under the concentration-time curve (AUC)

  Pharmacokinetics at multiple time points during the first 4 weeks of dosing

• Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: time to reach maximum observed concentration (Tmax)

  Pharmacokinetics at multiple time points during the first 4 weeks of dosing

Study Arms (2)

Escalation Phase: BMS-906024

EXPERIMENTAL

BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity

Drug: BMS-906024

Expansion Phase: BMS-906024 + Dexamethasone

EXPERIMENTAL

BMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity

Drug: BMS-906024; Drug: Dexamethasone

Interventions

BMS-906024 DRUG

Also known as: Notch inhibitor

Escalation Phase: BMS-906024; Expansion Phase: BMS-906024 + Dexamethasone

Dexamethasone DRUG

Also known as: Baycadron

Expansion Phase: BMS-906024 + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
• Life expectancy of at least 2 months
• Performance status (PS) 0-1 (a measure of the ability to carry out activities of daily living); subjects with PS 2 are eligible if due to disease related symptoms
• Prior anti-cancer treatment permitted (with specific criteria)
• Adequate organ function

You may not qualify if:

• Infection
• Elevated triglycerides
• Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
• Unable to tolerate bone marrow biopsy
• Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (6)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The University Of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Local Institution

Marseille, 13273, France

Location

Local Institution

Paris, 75475, France

Location

Johann Wolfgang Goethe Universitaet

Frankfurt am Main, 60590, Germany

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

BMS-906024; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: June 2, 2011
• Study Start: September 28, 2011
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

DE (1); US (3); FR (2)