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Bexxar

Phase 1

B-cell Lymphoma | Small molecule | Oncology |GSK plc|Trials Updated: Jul 25, 2017

Bexxar development status

Highest phase Phase 1
Registered trials 6 across 3 sponsors since Aug 2001

Bexxar target and mechanism

ModalitySmall molecule

Also known as Iodine-131 Anti-B1 Antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment27

FDA Designations

No designations recorded

Bexxar clinical trials

Bexxar · 2 trials · 3 indications

Phase 1 2
NCT00434629Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous TransplantB-cell Lymphoma
COMPLETED16 Analytics
NCT00992758Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma (NHL) Patients With Greater Than 25% Bone Marrow InvolvementLymphoma, Non-Hodgkin
COMPLETED11 Analytics
PHASE1COMPLETED
Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant
B-cell LymphomaUnlock trial analytics
PHASE1COMPLETED
Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma (NHL) Patients With Greater Than 25% Bone Marrow Involvement
Lymphoma, Non-HodgkinUnlock trial analytics

Study Endpoints

Primary Endpoints

dose-limiting toxicity
Week 7 after Bexxar
maximum tolerated dose
Week 7 after Bexxar
The maximum tolerated dose of Iodine-131 Anti B-1 Antibody in patients with previously treated NHL having more than 25% bone marrow involvement with lymphoma.
Approximately 2 years

Secondary Endpoints

overall response rate
Week 13 after Bexxar
progression-free survival
5 years after Bexxar
time to treatment failure
5 years after Bexxar
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment, Non-Randomized, Open LabelEXPERIMENTALTreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Interventions

NameTypeDescription
BexxarDRUGDay 0: Tositumomab, IV (in the vein) followed by test dose of 131I-Tositumomab, IV (in the vein) to determine treatment dose of 131I-Tositumomab. 1-2 weeks after Day 0: Tositumomab, IV (in the vein) followed by therapeutic dose 131I-Tositumomab (in the vein).
Iodine-131 Anti-B1 AntibodyBIOLOGICALDosimetric Dose: 450 mg unlabeled Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody of which 1-2 mg has been labeled with 5 mCi of Iodine-131 infused over 20 minutes. Therapeutic Dose: 7-14 days after dosimetric dose, 450 mg Anti-B1 Antibody infused over 1 hour or longer followed by 35 mg of Anti-B1 Antibody labeled with the subject-specific dose of Iodine-131 to deliver the desired total body radiation, infused over 20 minutes The dose escalation will be initiated at 45 cGy and will be increased in 10 cGy increments until the maximum tolerated dose (MTD) is reached.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * CD20 positive B-cell lymphoma * Confirmed relapsed/refractory disease following autologous transplant * Age ≤ 75 years * Performance status 0 or 1 * Creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min * Total bilirubin, AST, and ALT ≤ 1.5 x upper limit of normal (u...

Countries:United States
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Competitive Landscape -Cutaneous T-Cell Lymphoma 8 trials (matched to "B-cell Lymphoma")

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Incyte CorporationINCY1PHASE2Ruxolitinib
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