NCT00081510 is a Phase 2 clinical trial of Lonafarnib in Breast Cancer, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT00081510?

NCT00081510 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00081510?

Interventions in NCT00081510: Lonafarnib, Placebo, anastrozole.

What condition does NCT00081510 study?

NCT00081510 studies Breast Cancer.

Is NCT00081510 still recruiting?

NCT00081510 is currently completed. Last updated 26 March 2015.

Last reviewed 2015-03-26 · How we verify

NCT00081510

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer

Completed Phase 2 Last updated 26 March 2015

What this trial tests

Phase 2 trial testing Lonafarnib in Breast Cancer in 110 participants. Completed in 1 May 2009.

Timeline

1 December 2003

Primary endpoint
1 May 2009

1 May 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	110
Start date	1 December 2003
Primary completion	1 May 2009
Estimated completion	1 May 2009

Drugs / interventions tested

Lonafarnib (LONAFARNIB) — full drug profile →
Placebo
anastrozole (anastrozole) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Eligibility, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

Primary Objective(s): * To compare the activity (progression-free survival \[PFS\]) of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive ADVANCED breast cancer. Secondary Objective(s): * To determine the effects of anastrozole in combination with lonafarnib on objective response, duration of response, overall survival, and safety in subjects with advanced breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Protein lipidation in health and disease: molecular basis, physiological function and pathological implication.
Yuan Y, Li P, Li J, Zhao Q, et al · · 2024 · cited 56× · PMID 38485938 · DOI 10.1038/s41392-024-01759-7

Verify or expand the search:

Other trials of Lonafarnib

Trials testing the same drug.

NCT05229991 — Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection · Phase 3 · unknown
NCT03719313 — Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a · Phase 3 · completed
NCT03600714 — Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon · Phase 2 · completed
NCT02511431 — Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir · Phase 2 · completed
NCT00102648 — Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Pr · Phase 1 · active not recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00081510 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 26 March 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00081510.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing