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TP-38

Phase 2

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

TP-38 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2003

TP-38 target and mechanism

ModalitySmall molecule

Also known as immunotoxin

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment112

FDA Designations

No designations recorded

TP-38 clinical trials

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 indications.

What does TP-38 target?

TP-38 is a small molecule therapeutic being developed for oncology. Its specific molecular target has not been disclosed in available clinical trial information.

Who makes TP-38?

TP-38 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA.

What phase is TP-38 in?

TP-38 is in Phase 2 clinical development. It has completed two Phase 2 trials, and it remains an investigational drug that is not approved for commercial use.

What clinical trials is TP-38 in?

TP-38 has been studied in two completed Phase 2 trials: NCT00071539 and NCT00104091. Both trials enrolled 56 participants each and evaluated the drug in patients with glioblastoma multiforme, including recurrent disease.

Is TP-38 the same as any other drug?

TP-38 is also known by the name TP38. It is a distinct investigational agent being developed by Teva Pharmaceutical Industries Limited for glioblastoma multiforme.