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Tipifarnib

Phase 2

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

Target and mechanism

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

Clinical trial landscape

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 an investigational small molecule 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 disease. It is not an approved therapy and remains in clinical development.

Who is developing tipifarnib?

Tipifarnib is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical research evaluating the drug in acute myeloid leukemia.

What phase is tipifarnib in?

Tipifarnib is in Phase 2 development. A single Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.

What clinical trials is tipifarnib in?

Tipifarnib has been studied in one completed Phase 2 trial, NCT00354146, titled a study of farnesyl transferase inhibitor R115777 (tipifarnib) in patients with refractory or relapsed acute myeloid leukemia. The trial enrolled 252 patients aged 18 years and older and was uncontrolled.

Is tipifarnib the same as R115777?

Yes, tipifarnib is also known as R115777. The two names refer to the same investigational small molecule developed by Johnson & Johnson for acute myeloid leukemia.