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BMS-906024

Phase 1

Lymphoblastic Leukemia, Acute T-cell | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 30, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01363817Study 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 LymphomaPHASE1 COMPLETED 31 — — Sep 28, 2011Feb 7, 2018Jul 30, 20196 United States, France +1
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Study Endpoints
Primary Endpoints
Number of subjects with adverse events as a measure of safety and tolerability
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 Endpoints
Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI)
Disease assessments at least every 8 weeks during treatment
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax)
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)
Pharmacokinetics at multiple time points during the first 4 weeks of dosing
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Escalation Phase: BMS-906024EXPERIMENTALBMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity
Expansion Phase: BMS-906024 + DexamethasoneEXPERIMENTALBMS-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
NameTypeDescription
BMS-906024DRUG -
DexamethasoneDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 *...

Countries:United StatesFranceGermany
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