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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01363817
• Date of registration: 22/04/2011
• Primary sponsor: Bristol-Myers Squibb
• Public 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
• Scientific 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
• Date of first enrolment: September 2011
• Target sample size: 42
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01363817
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France, Germany, United States

Contacts

• Name: For participation information at a USA site use a phone number below. For site information outside the USA please email:

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoblastic Leukemia, Acute T-cell

Precursor T-Cell Lymphoblastic Lymphoma

Intervention(s)

Drug: BMS-906024

Drug: Dexamethasone

Primary Outcome(s)

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(s)

Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI) [Time Frame: Disease assessments at least every 8 weeks during treatment]

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]

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]

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: 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: 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: time to reach maximum observed concentration (Tmax) [Time Frame: Pharmacokinetics at multiple time points during the first 4 weeks of dosing]

Secondary ID(s)

2010-022727-29

CA216-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors