Overview

This trial is active, not recruiting.

Conditions lymphoblastic leukemia, acute t-cell, precursor t-cell lymphoblastic lymphoma
Treatments bms-906024, dexamethasone
Phase phase 1
Sponsor Bristol-Myers Squibb
Start date September 2011
End date December 2016
Trial size 42 participants
Trial identifier NCT01363817, 2010-022727-29, CA216-002

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Notch inhibitor
(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
bms-906024 Notch inhibitor
dexamethasone Baycadron

Primary Outcomes

Measure
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 Outcomes

Measure
Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI)
time frame: Disease assessments at least every 8 weeks during treatment
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half)
time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose)
time frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells)
time frame: Pharmacodynamic sampling: in blood during the first 8 weeks of dosing

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Description Minimum Age: 10 years and older at selected sites
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.