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leflunomide

Phase 3

Brain and Central Nervous System Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 13, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

leflunomide · 3 trials · 2 indications

Phase 3 1Phase 2 2
NCT00003293SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma MultiformeBrain and Central Nervous System Tumors
COMPLETED- Analytics
PHASE3COMPLETED
SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System TumorsUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
PurposeTREATMENT

Interventions

NameTypeDescription
leflunomideDRUG -
procarbazine hydrochlorideDRUG -
mitoxantrone hydrochlorideDRUG -
prednisoneDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

DISEASE CHARACTERISTICS: Histologically proven refractory or recurrent supratentorial glioblastoma multiforme Bidimensionally measurable, enhancing residual disease by T1-weighted gadolinium-enhanced MRI required within 15 days prior to treatment Stable dose of corticosteroids required for at least ...

Countries:United StatesCanada
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Frequently asked questions about leflunomide

What is leflunomide used for?

Leflunomide is being studied for use in oncology, specifically for prostate cancer and brain and central nervous system tumors. It is an investigational small molecule being developed by Pfizer, Inc. (PFE). In clinical trials, it has been evaluated in patients with glioblastoma multiforme, anaplastic astrocytoma, and stage IV prostate cancer.

What does leflunomide target?

Leflunomide is a small molecule that inhibits dihydroorotate dehydrogenase, an enzyme involved in pyrimidine synthesis. By blocking this enzyme, it disrupts DNA synthesis and cell proliferation, which is relevant to its anticancer activity. This mechanism is being explored in the treatment of brain tumors and prostate cancer.

Who makes leflunomide?

Leflunomide is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's efficacy in treating prostate cancer and brain and central nervous system tumors.

What phase is leflunomide in?

Leflunomide is in Phase 3 clinical development for brain and central nervous system tumors, specifically glioblastoma multiforme. It has also completed Phase 2 trials for anaplastic astrocytoma and prostate cancer. The drug is investigational and has not been approved by the FDA for these oncology indications.

What clinical trials is leflunomide in?

Leflunomide has been studied in three completed clinical trials. NCT00003293 was a Phase 3 trial comparing SU-101 with procarbazine in glioblastoma multiforme. NCT00003775 was a Phase 2 trial in anaplastic astrocytoma. NCT00004071 was a Phase 2 trial combining leflunomide with mitoxantrone and prednisone in stage IV prostate cancer.

Is leflunomide the same as SU-101?

In the clinical trial NCT00003293, leflunomide is referred to as SU-101. This trial compared SU-101 with procarbazine in patients with glioblastoma multiforme. The drug is also known by the name leflunomide in other trials, such as NCT00003775 and NCT00004071.