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MGd

Phase 3

Metastatic Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Oct 31, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment430
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00003563Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain MetastasesPHASE3 COMPLETED 430Aug 1, 1998Jun 1, 2005Oct 31, 201335 United States, Canada
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
WBRTEXPERIMENTAL3 Gy of WBRT daily for a total of 10 days
MGdEXPERIMENTALIV does of 5.0 mg/kg MGd plus WBRT
Interventions
NameTypeDescription
WBRTRADIATION3 GY of WBRT daily for a total of 10 days
MGdDRUG5.0 mg /kg MGd plus WBRT
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

DISEASE CHARACTERISTICS: Histologically proven solid tumor with parenchymal brain metastasis Solitary metastasis eligible only if refused surgery or surgical resection deemed inappropriate No leptomeningeal metastases or subarachnoid spread of tumor No small cell lung cancer, germ cell tumors, lymph...

Countries:United StatesCanada
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