Recent Updates
Recently added Catalysts

Lonafarnib

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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 -
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
Unlock Competitive Intelligence

Frequently asked questions about Lonafarnib

What is Lonafarnib used for?

Lonafarnib is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in combination with anastrozole for advanced breast cancer in female patients. The drug is currently in Phase 2 clinical development and is not approved for any use.

What does Lonafarnib target?

Lonafarnib is a small molecule that targets farnesyltransferase, an enzyme involved in protein prenylation. By inhibiting this enzyme, it may disrupt signaling pathways that contribute to cancer cell growth. This mechanism is being explored in the context of advanced breast cancer.

Who makes Lonafarnib?

Lonafarnib is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in breast cancer.

What phase is Lonafarnib in?

Lonafarnib is in Phase 2 clinical development for breast cancer. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under investigation for this indication.

What clinical trials is Lonafarnib in?

Lonafarnib has been studied in one completed Phase 2 clinical trial, identified as NCT00081510. This randomized, double-blind, active-controlled trial enrolled 110 female participants with advanced breast cancer and evaluated the combination of anastrozole plus lonafarnib compared to anastrozole plus placebo.

Is Lonafarnib the same as SCH 66336?

Yes, Lonafarnib is also known as SCH 66336. The clinical trial NCT00081510, which studied the drug for advanced breast cancer, refers to it as SCH 66336 in the trial title. Both names refer to the same investigational compound.