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TP-38

Phase 2

Glioblastoma Multiforme | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Jan 20, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

TP-38 · 2 trials · 2 indications

Phase 2 2
NCT00104091Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain TumorsGlioblastoma Multiforme
COMPLETED56 Analytics
NCT00071539Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain TumorsRecurrent Glioblastoma Multiforme
COMPLETED56 Analytics
PHASE2COMPLETED
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
Glioblastoma MultiformeUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
Recurrent Glioblastoma MultiformeUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity
26 weeks
Survival
28 weeks

% patients alive

Secondary Endpoints

Efficacy parameters including time to progression, safety, and survival
26 weeks
Time to progression (TTP)
28 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
TP38 50 ng/mLEXPERIMENTAL -
TP38 100 ng/mLEXPERIMENTAL -

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.
TP38DRUGrecombinant chimeric protein
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about TP-38

What is TP-38 used for?

TP-38 is an investigational small molecule being studied for the treatment of glioblastoma multiforme, including recurrent glioblastoma multiforme. It is in Phase 2 clinical development for these oncology indications.

Who makes TP-38?

TP-38 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma multiforme.

What phase is TP-38 in?

TP-38 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for the treatment of glioblastoma multiforme.

What clinical trials is TP-38 in?

TP-38 has been studied in two completed Phase 2 clinical trials: NCT00071539 and NCT00104091. Both trials evaluated the drug in patients with recurrent grade 4 malignant brain tumors, including glioblastoma multiforme, with a combined enrollment of 56 participants.

Is TP-38 the same as any other drug?

TP-38 is not known to have alternative names. It is a distinct investigational small molecule being developed by Teva Pharmaceutical Industries for the treatment of glioblastoma multiforme.