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IDEC-152

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

IDEC-152 · 1 trial · 1 indication

Phase 1 1
NCT00046488Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia
COMPLETED70 Analytics
PHASE1COMPLETED
Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic LeukemiaUnlock trial analytics

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 to 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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Frequently asked questions about IDEC-152

What is IDEC-152 used for in Chronic Lymphocytic Leukemia?

IDEC-152 is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It was evaluated in a Phase 1 clinical trial to assess its safety and efficacy in patients with this condition. The drug is not approved and remains in clinical development.

Who makes IDEC-152?

IDEC-152 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company sponsored the clinical trial of this investigational drug for Chronic Lymphocytic Leukemia.

What phase is IDEC-152 in?

IDEC-152 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is IDEC-152 in?

IDEC-152 has been studied in one completed clinical trial, identified as NCT00046488. This Phase 1 study, titled 'Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL),' enrolled 70 participants in the United States and was open to adults aged 18 years and older.

Is IDEC-152 FDA approved?

IDEC-152 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for Chronic Lymphocytic Leukemia. The drug remains in clinical development and has not received marketing approval from the FDA or any other regulatory agency.