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Tipifarnib; Zarnestra; R115777

Phase 3

Acute Myeloid Leukemia | Small molecule | Oncology |Johnson & Johnson|Last Updated: Sep 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment457

FDA Designations

No designations recorded

Clinical trial landscape

Tipifarnib; Zarnestra; R115777 · 1 trial · 1 indication

Phase 3 1
NCT00093990Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia
COMPLETED457 Analytics
PHASE3COMPLETED
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival

Secondary Endpoints

Compare patients treated with tipifarnib and patients treated with best supportive care: progression-free survival; complete remission rate; rate of morphologic leukemia-free state; one-year survival estimate and health resources utilization.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Tipifarnib;Zarnestra; R115777DRUG -
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Eligibility Criteria

Age Range70 Years to 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Newly diagnosed or re-lapsing AML * Patient not medically fit for combination induction chemotherapy * Pathologic confirmation of AML (= or \> 20% bone marrow leukemic blasts) * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Exclusion Criteria: * Pr...

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Frequently asked questions about Tipifarnib; Zarnestra; R115777

What is Tipifarnib used for?

Tipifarnib, also known as Zarnestra or R115777, is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 3 clinical development and has not been approved by the FDA.

What does Tipifarnib target?

Tipifarnib is a small molecule that targets farnesyltransferase, an enzyme involved in cell signaling. By inhibiting this enzyme, it aims to disrupt cancer cell growth and survival in Acute Myeloid Leukemia.

Who makes Tipifarnib?

Tipifarnib is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 3 clinical trials for Acute Myeloid Leukemia.

What phase is Tipifarnib in?

Tipifarnib is in Phase 3 clinical development for Acute Myeloid Leukemia. It is an investigational drug and has not received FDA approval. One Phase 3 trial has been completed, with no active trials currently ongoing.

What clinical trials is Tipifarnib in?

Tipifarnib has one completed Phase 3 trial, NCT00093990, which compared Tipifarnib to best supportive care in newly diagnosed Acute Myeloid Leukemia patients aged 70 years and older. The trial enrolled 457 participants and was not blinded or controlled.

Is Tipifarnib the same as Zarnestra or R115777?

Yes, Tipifarnib is also known as Zarnestra and R115777. These names refer to the same investigational drug being developed by Johnson & Johnson for Acute Myeloid Leukemia.