Clinical Trial: 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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Lymp

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 Summary: Minimum Age: 10 years and older at selected sites
Sponsor: Bristol-Myers Squibb

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: April 22, 2011
Date Started: September 28, 2011
Date Completion: October 2, 2017
Last Updated: May 15, 2017
Last Verified: May 2017