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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01363817
First received: April 22, 2011
Last updated: October 13, 2014
Last verified: February 2014

April 22, 2011
October 13, 2014
September 2011
March 2015   (final data collection date for primary outcome 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01363817 on ClinicalTrials.gov Archive Site
  • Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI) [ Time Frame: Disease assessments at least every 8 weeks during treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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

Minimum Age: 10 years and older at selected sites

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoblastic Leukemia, Acute T-cell
  • Precursor T-Cell Lymphoblastic Lymphoma
  • Drug: BMS-906024
    Other Name: Notch inhibitor
  • Drug: Dexamethasone
    Other Name: Baycadron
  • Experimental: Escalation Phase: BMS-906024
    BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity
    Intervention: Drug: BMS-906024
  • Experimental: Expansion Phase: BMS-906024 + Dexamethasone
    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
    Interventions:
    • Drug: BMS-906024
    • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
March 2015
March 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   France,   Germany
 
NCT01363817
CA216-002, 2010-022727-29
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP