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acenocoumarol

Phase 1

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

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, Neoplasms
NCT018518249
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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 used for?

Acenocoumarol is a small molecule being studied for use in malignant melanoma and neoplasms. It is currently in Phase 1 clinical development as an investigational drug. The drug is being evaluated in oncology, specifically in patients with BRAFV600 mutation-positive metastatic malignancy.

What does acenocoumarol target?

Acenocoumarol is being studied in combination with vemurafenib, a BRAF inhibitor, in patients with BRAFV600 mutation-positive metastatic malignancy. The clinical trial evaluates the effect of vemurafenib on the pharmacokinetics of acenocoumarol, though acenocoumarol itself is not described as targeting a specific molecular target in the available data.

Who makes acenocoumarol?

Acenocoumarol is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this drug in the oncology therapeutic area.

What phase is acenocoumarol in?

Acenocoumarol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed for this drug.

What clinical trials is acenocoumarol in?

Acenocoumarol has one completed clinical 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 study enrolled 9 participants across multiple countries including Australia, Germany, Greece, Hungary, Netherlands, New Zealand, Portugal, Serbia, and Spain.

Is acenocoumarol the same as any other drug?

Acenocoumarol is also known by other names, though the specific alternative names are not provided in the available data. It is a distinct small molecule being investigated for oncology indications, and readers should verify any name variations through official sources.