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IDEC-152

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |Biogen Inc.|Last Updated: Sep 16, 2013

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
RandomizedUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00046488Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)PHASE1 COMPLETED 70 — — Sep 1, 2002Mar 1, 2010Sep 16, 20136 United States
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Study Endpoints
Primary Endpoints
Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
48 months
Characterize the safety profile of IDEC-152
48 months
Secondary Endpoints
Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL
48 months
Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL
48 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Interventions
NameTypeDescription
IDEC-152DRUG6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Signed IRB-approved informed consent. * Greater than 18 years of age * Proof of CD23+ CLL or small lymphocytic lymphoma (SLL) * Progressive disease after at least 1 course of chemotherapy * Acceptable hematologic status, liver function, renal function, and pulmonary function *...

Countries:United States
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