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IDEC-114

Phase 1

Non-Hodgkin's Lymphoma | 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
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment132
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00048555Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's LymphomaPHASE1 COMPLETED 90 — — Nov 1, 2002Nov 1, 2010Sep 16, 201322 United States
NCT00575068Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's LymphomaPHASE1 COMPLETED 42 — — Jan 1, 2002Nov 1, 2010Jun 8, 20124 United States
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Study Endpoints
Primary Endpoints
To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the study
March 2010
To characterize the safety profile of IDEC-114 and to define their duration and reversibility
March 2010
Secondary Endpoints
To evaluate PK
March 2010
To evaluate efficacy
March 2010
To monitor for the presence of human anti galiximab antibody and human antichimeric antibody formation
March 2010
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
IDEC-114DRUGDose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Signed IRB-approved informed consent * Greater than or equal to 18 years of age * Proof of follicular lymphoma * Progressive disease requiring treatment after at least 1 prior standard therapy * Acceptable hematologic status, liver function, and renal function * Patients of re...

Countries:United States
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