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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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-906024

Dexamethasone

About this trial

This is an interventional treatment trial for Lymphoblastic Leukemia, Acute T-cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Dana Farber Cancer Institute
Memorial Sloan Kettering Cancer Center
The University Of Texas MD Anderson Cancer Center
Local Institution
Local Institution
Johann Wolfgang Goethe Universitaet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Escalation Phase: BMS-906024

Expansion Phase: BMS-906024 + Dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half)

Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose)

Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells)

Full Information

NCT ID

NCT01363817

First Posted

April 22, 2011

Last Updated

July 29, 2019

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01363817

Brief Title

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

Official Title

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 28, 2011 (Actual)

Primary Completion Date

February 7, 2018 (Actual)

Study Completion Date

February 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

Minimum Age: 10 years and older at selected sites

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escalation Phase: BMS-906024

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Phase: BMS-906024 + Dexamethasone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

BMS-906024

Other Intervention Name(s)

Notch inhibitor

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Baycadron

Primary Outcome Measure Information:

Title

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

Time Frame

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 Outcome Measure Information:

Title

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

Time Frame

Disease assessments at least every 8 weeks during treatment

Title

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

Time Frame