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Tipifarnib

Phase 2

Leukemia, Nonlymphocytic, Acute | Small molecule | Oncology |Johnson & Johnson|Trials Updated: Feb 1, 2011

Tipifarnib development status

Highest phase Phase 2
Registered trials 13 across 3 sponsors since Nov 2002

Tipifarnib target and mechanism

Molecular targetFNTA, FNTB
Target classInhibitor
ModalitySmall molecule

Also known as tipifarnib (R115777)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment252

FDA Designations

No designations recorded

Tipifarnib clinical trials

Tipifarnib · 1 trial · 1 indication

Phase 2 1
NCT00354146A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.Leukemia, Nonlymphocytic, Acute
COMPLETED252 Analytics
PHASE2COMPLETED
A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.
Leukemia, Nonlymphocytic, AcuteUnlock trial analytics

Study Endpoints

Primary Endpoints

The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.

Secondary Endpoints

These objectives are to determine the objective remission rate, duration of remission, time to disease progression/progression-free survival, overall survival, and the clinical benefit/quality of life (QOL). The safety profile will also be determined.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
tipifarnib (R115777)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Refractory or relapsed Acute myeloid leukemia (AML) * Eastern Cooperative Oncology Group (ECOG) performance of 0-2 * any value of WBC * able to eat food and medication orally * females must use contraception and not be pregnant Exclusion Criteria: * .Not in another study wit...

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Frequently asked questions about Tipifarnib

What is Tipifarnib used for?

Tipifarnib is being studied for the treatment of acute myeloid leukemia, also described as nonlymphocytic acute leukemia. It has been evaluated in patients with relapsed or refractory acute myeloid leukemia in a Phase 2 clinical trial. It is an investigational small molecule and is not described as approved for any indication.

What does Tipifarnib target?

Tipifarnib targets the farnesyltransferase enzymes FNTA and FNTB. It acts as an inhibitor of these enzymes. By inhibiting farnesyltransferase, tipifarnib interferes with the prenylation of proteins such as RAS, which is relevant to its investigation in acute myeloid leukemia.

Who is developing Tipifarnib?

Tipifarnib is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is responsible for the clinical development of the drug, including the Phase 2 study in acute myeloid leukemia.

What phase is Tipifarnib in?

Tipifarnib is in Phase 2 clinical development. It has been evaluated in a completed Phase 2 trial in patients with relapsed or refractory acute myeloid leukemia. It is an investigational agent and is not described as approved by the FDA for any indication.

What clinical trials is Tipifarnib in?

Tipifarnib has been studied in a Phase 2 clinical trial identified as NCT00354146. The trial was titled "A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia." It enrolled 252 patients and has been completed.

Is Tipifarnib the same as R115777?

Yes, tipifarnib is also known as R115777. The alternative designation R115777 appears in the title of its Phase 2 trial in acute myeloid leukemia, confirming that both names refer to the same investigational small molecule.