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BCL201

Phase 1

Follicular Lymphoma, Mantle Cell Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Feb 24, 2020

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
CONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02603445Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCLPHASE1 COMPLETED 20Nov 16, 2015Jul 10, 2018Feb 24, 20207 United States, Austria +2
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
24 months

Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes

Secondary Endpoints
Incidence rate of dose limiting toxicities (DLTs)
24 months
Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15
Cycle = 28 days
Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib)
24 Months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Follicular lymphoma (FL)EXPERIMENTAL -
Mantle cell lymphoma (MCL)EXPERIMENTAL -
Interventions
NameTypeDescription
BCL201DRUG -
IdelalisibDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically confirmed diagnosis of FL or MCL according to WHO 2008 * Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens. * Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imagi...

Countries:United StatesAustriaFranceGermany
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