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Completed

NCT Number: NCT01363817

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Marseille, France

Loading trial locations.

About this study

Minimum Age: 10 years and older at selected sites

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BMS-906024

Drug

Other names: Notch inhibitor

Dexamethasone

Drug

Other names: Baycadron

Primary outcomes

  1. 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

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

    Time frame: Disease assessments at least every 8 weeks during treatment

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2011
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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