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rofecoxib

Phase 4FDA approved

Prostate Cancer | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: May 9, 2017

rofecoxib development status

FDA approval on record May 20, 1999 as Vioxx
Approval holderMerck
ApplicationNDA021042
Highest phase Phase 4 run by Pfizer (NCT00657449)
Phase scored for MRKPhase 3
Registered trials 13 across 5 sponsors since May 2003

rofecoxib target and mechanism

Molecular targetPTGS2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL122

Also known as MK0966

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment15,000

FDA Designations

No designations recorded

rofecoxib clinical trials

rofecoxib · 1 trial · 1 indication

Phase 3 1
NCT00060476Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)Prostate Cancer
COMPLETED15,000 Analytics
PHASE3COMPLETED
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to prostate cancer
Duration of Treatment

Secondary Endpoints

Time to aggressive prostate cancer
Duration of Treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
rofecoxibDRUG -
Comparator: placebo (unspecified)DRUG -
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Eligibility Criteria

Age Range50 Years to 75 Years
SexMALE
Healthy VolunteersNo

Regular PSA testing and study biopsies required.

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Competitive Landscape -Prostate Cancer 417 trials

Top 20 of 55 competitors

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Frequently asked questions about rofecoxib

What is rofecoxib?

Rofecoxib is a small molecule drug developed by Merck & Company, Inc. (ticker MRK) that has been studied in oncology, specifically for prostate cancer. It is a PTGS2 inhibitor. The compound is identified in ChEMBL as CHEMBL122 and has been evaluated in a Phase 3 clinical trial.

What is rofecoxib used for in prostate cancer?

Rofecoxib was studied for the prevention of prostate cancer. The Phase 3 trial NCT00060476, titled Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201), enrolled 15,000 male participants aged 50 years and older. The study is completed, and rofecoxib remains an investigational agent in this setting.

What does rofecoxib target?

Rofecoxib targets PTGS2, also known as cyclooxygenase-2. It acts as an inhibitor of this enzyme. PTGS2 inhibition is the mechanism attributed to rofecoxib in its clinical development for prostate cancer prevention, as studied by Merck in the Phase 3 trial NCT00060476.

Who makes rofecoxib?

Rofecoxib was developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 3 prostate cancer prevention study of rofecoxib, registered as NCT00060476 under the code MK0966. The company is the developer associated with this asset.

What phase is rofecoxib in?

Rofecoxib reached Phase 3 clinical development for prostate cancer. The single registered trial, NCT00060476, was a Phase 3 study that has been completed, with no active trials currently listed. Rofecoxib is an investigational drug in this oncology indication rather than an approved prostate cancer therapy.

What clinical trials is rofecoxib in?

Rofecoxib was evaluated in one clinical trial, NCT00060476, titled Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201). This Phase 3 study was randomized and double blind, enrolled 15,000 male participants aged 50 and older, and is now completed. No active trials are listed.