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IDEC-114

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Biogen Inc.|Last Updated: Sep 16, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

IDEC-114 · 2 trials · 1 indication

Phase 1 2
NCT00048555Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED90 Analytics
NCT00575068Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED42 Analytics
PHASE1COMPLETED
Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics
PHASE1COMPLETED
Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics

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 to 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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Frequently asked questions about IDEC-114

What is IDEC-114 used for?

IDEC-114 is an investigational small molecule being studied for the treatment of Non-Hodgkin's Lymphoma. It has been evaluated in Phase 1 clinical trials, but it is not approved by the FDA and remains in clinical development.

Who makes IDEC-114?

IDEC-114 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The drug is in Phase 1 clinical development for Non-Hodgkin's Lymphoma.

What phase is IDEC-114 in?

IDEC-114 is in Phase 1 clinical development. Two Phase 1 trials have been completed, but the drug is still investigational and has not received FDA approval.

What clinical trials is IDEC-114 in?

IDEC-114 has been studied in two completed Phase 1 trials. NCT00048555 evaluated IDEC-114 in combination with Rituxan in 90 patients, and NCT00575068 evaluated IDEC-114 alone in 42 patients, both for Non-Hodgkin's Lymphoma.

Is IDEC-114 the same as Rituxan?

No, IDEC-114 is not the same as Rituxan. IDEC-114 is a separate investigational small molecule being studied for Non-Hodgkin's Lymphoma, while Rituxan is a different drug that was used in combination with IDEC-114 in one clinical trial.