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Lonafarnib

Phase 3

Breast Cancer | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: Apr 15, 2015

Lonafarnib development status

Highest phase Phase 3 (NCT00109538)
Phase scored for MRKPhase 2
Registered trials 3 across 2 sponsors since Apr 2004

Lonafarnib target and mechanism

Molecular targetFNTA, FNTB
Target classInhibitor
ModalitySmall molecule

Also known as SCH 66336

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Lonafarnib clinical trials

Lonafarnib · 1 trial · 1 indication

Phase 2 1
NCT00081510Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)Breast Cancer
COMPLETED110 Analytics
PHASE2COMPLETED
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (PFS)
When approximately 70 subjects have progressed

Secondary Endpoints

Objective response rate (adjusted RECIST criteria), duration of response, and overall survival
When approximately 70 subjects have progressed
To access the exposure and pk of lonafarnib and anastrazole in the subject population.
When approximately 70 subjects have progressed
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lonafarnib plus AnastrozoleEXPERIMENTALParticipants receive lonafarnib 200 mg orally (PO) twice per day (BID) beginning on Day 1 Cycle 1 and continuing until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole 1 mg, PO, once per day (QD) for as long as the participant is receiving lonafarnib
Placebo plus AnastrozoleACTIVE_COMPARATORParticipants receive placebo to lonafarnib PO BID beginning on Day 1 Cycle 1 until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole, 1mg PO QD for as long as the participant is receiving placebo

Interventions

NameTypeDescription
LonafarnibDRUG -
PlaceboDRUG -
anastrozoleDRUG -
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Eligibility Criteria

SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Postmenopausal women who have histologically-confirmed breast cancer with the following characteristics: * estrogen and/or progesterone receptor positive, * locally advanced disease * distant metastatic disease, stage 4 * Subjects eligible for single-agent treatment wit...

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Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about Lonafarnib

What is Lonafarnib used for?

Lonafarnib has been studied in breast cancer. It was evaluated in a Phase 2 trial in combination with anastrozole for the treatment of advanced breast cancer in female patients. The trial compared anastrozole plus Lonafarnib against anastrozole plus placebo.

What does Lonafarnib target?

Lonafarnib targets the enzymes FNTA and FNTB, which are farnesyltransferase subunits. It acts as an inhibitor of these enzymes. This mechanism is being investigated in oncology, specifically in breast cancer.

Who is developing Lonafarnib?

Lonafarnib is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is responsible for its clinical development.

What phase is Lonafarnib in?

Lonafarnib is in Phase 2 clinical development for breast cancer. It is an investigational small molecule and has not been approved by the FDA for this indication.

What clinical trials is Lonafarnib in?

Lonafarnib has been studied in one completed Phase 2 trial, NCT00081510, titled Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer. The trial enrolled 110 female patients and was randomized, double-blind, and active-controlled.

Is Lonafarnib the same as SCH 66336?

Yes, Lonafarnib is also known as SCH 66336. This alternative name appears in the title of its clinical trial, NCT00081510, which refers to the drug as Lonafarnib (SCH 66336).