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ZARNESTRA, tipifarnib, R115777

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |Johnson & Johnson|Last Updated: Feb 1, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

ZARNESTRA, tipifarnib, R115777 · 3 trials · 3 indications

Phase 2 3
NCT00050141Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast CancerBreast Cancer
COMPLETED121 Analytics
NCT00050154Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)Myelodysplastic Syndrome
COMPLETED82 Analytics
NCT00048503Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and OlderAcute Myeloid Leukemia
COMPLETED88 Analytics
PHASE2COMPLETED
Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer
Breast CancerUnlock trial analytics
PHASE2COMPLETED
Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)
Myelodysplastic SyndromeUnlock trial analytics
PHASE2COMPLETED
Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparisons between the two treatment groups will be made for patients who have achieve a confirmed Complete Response (CR) or Partial Response (PR).
The purpose of this research study is to determine if tipifarnib leads to a complete response for in patients with high-risk Myelodysplastic Syndrome (MDS).
The primary objective is to determine relapse-free survival (RFS) at 1 year in patients, 60 years and older with AML, who receive tipifarnib treatment.

Secondary Endpoints

Effectiveness will be assessed by time to disease progression; time to treatment failure; duration of response; clinical benefit; duration of clinical benefit; survival time. The study will include evaluations of safety and tolerability.
Efficacy will be assessed by evaluation of bone marrow and hematologic laboratory tests. Safety will be assessed by evaluation of adverse events and clinical laboratory tests.
Secondary objectives, assess: overall survival; time to relapse; the safety profile of treatment with tipifarnib; the population pharmacokinetics of tipifarnib; DNA analysis of genetic variability; RNA analysis of differential gene expression.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ZARNESTRA, tipifarnib, R115777DRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer * Estrogen and/or progesterone positive disease * Progression of disease after antiestrogen therapy * Measurable disease * Postmenopausal * Eastern Cooperative Oncology Group (ECOG) performance...

Countries:United StatesBelgiumFranceNetherlandsRussiaUnited Kingdom
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Frequently asked questions about ZARNESTRA, tipifarnib, R115777

What is ZARNESTRA (tipifarnib) used for?

ZARNESTRA, also known as tipifarnib or R115777, is an investigational small molecule being studied for the treatment of acute myeloid leukemia, breast cancer, and myelodysplastic syndrome. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes ZARNESTRA (tipifarnib)?

ZARNESTRA (tipifarnib) is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical trials for oncology indications.

What phase is ZARNESTRA (tipifarnib) in?

ZARNESTRA (tipifarnib) is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for acute myeloid leukemia, breast cancer, and myelodysplastic syndrome.

What clinical trials is ZARNESTRA (tipifarnib) in?

ZARNESTRA (tipifarnib) has completed three Phase 2 trials: NCT00048503 in acute myeloid leukemia, NCT00050141 in advanced breast cancer, and NCT00050154 in high-risk myelodysplastic syndrome. These trials are completed, and no active trials are currently listed.

Is ZARNESTRA the same as tipifarnib or R115777?

Yes, ZARNESTRA is the brand name for tipifarnib, which is also known by the research code R115777. These names refer to the same investigational small molecule drug being developed by Johnson & Johnson for oncology indications.