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TP-38

Phase 2

Glioblastoma Multiforme | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: May 23, 2011

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
UNCONTROLLED
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00104091Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain TumorsPHASE2 COMPLETED 56Dec 1, 2004Jun 1, 2007May 23, 2011 -
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Study Endpoints
Primary Endpoints
Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity
26 weeks
Secondary Endpoints
Efficacy parameters including time to progression, safety, and survival
26 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL40 mL of TP-38 at a 100 nanograms/mL concentration
Interventions
NameTypeDescription
TP-38DRUGTP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: The patients must fulfill all the following criteria: * Previous histologically-confirmed diagnosis of primary GBM (glioblastoma multiforme, glioma grade 4 at time of first diagnosis). * Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous rese...

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