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acenocoumarol

Phase 1

Malignant Melanoma, Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since May 2013

Target and mechanism

Molecular targetVKORC1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

acenocoumarol · 1 trial · 1 indication

Phase 1 1
NCT01851824A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic MalignancyMalignant Melanoma, Neoplasms
COMPLETED9 Analytics
PHASE1COMPLETED
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Malignant Melanoma, NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC)
Pre-dose and up to 72 hours post-dose
Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax)
Pre-dose and up to 72 hours post-dose
Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Time to maximum plasma concentration (Tmax)
Pre-dose and up to 72 hours post-dose
Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Terminal half-life (t1/2)
Pre-dose and up to 72 hours post-dose
Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Apparent clearance (CL/F)
Pre-dose and up to 72 hours post-dose

Secondary Endpoints

Safety: Incidence of Adverse Events and Serious Adverse Events
approximately 1.5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Acenocoumarol + VemurafenibEXPERIMENTAL -

Interventions

NameTypeDescription
acenocoumarolDRUG4 mg single oral doses on Days 1 and 23
vemurafenibDRUG960 mg orally bid, 20 days (Days 4-23)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Adult patients, 18-70 years of age * Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have no acceptable standard treatment options * Eastern Cooperative Oncology ...

Countries:AustraliaGermanyGreeceHungaryNetherlandsNew ZealandPortugalSerbiaSpain
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Frequently asked questions about acenocoumarol

What is acenocoumarol?

Acenocoumarol is a small molecule drug candidate being developed by Roche Holding AG (ticker RHHBY). It is being studied in oncology, specifically in malignant melanoma and other neoplasms. It is an investigational agent in Phase 1 development and has not been approved for these cancer indications.

What does acenocoumarol target?

Acenocoumarol targets VKORC1 and acts as an inhibitor of this target. VKORC1 is the enzyme targeted by vitamin K antagonist anticoagulants. In this development program, the drug is being evaluated in patients with malignant melanoma and other neoplasms.

Who makes acenocoumarol?

Acenocoumarol is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor associated with the clinical development of this small molecule agent in oncology.

What phase is acenocoumarol in?

Acenocoumarol is in Phase 1 clinical development for malignant melanoma and neoplasms. It is an investigational drug and is not approved for these cancer indications. The Phase 1 program includes one completed trial with no active trials currently listed.

What clinical trials is acenocoumarol in?

Acenocoumarol has been studied in trial NCT01851824, titled A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy. This Phase 1 trial is completed, enrolled 9 patients, and was conducted in Australia, Germany, Greece, Hungary, the Netherlands, New Zealand, Portugal, Serbia, and Spain.