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phenprocoumon

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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment2

FDA Designations

No designations recorded

Clinical trial landscape

phenprocoumon · 1 trial · 1 indication

Phase 1 1
NCT01849666A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic MalignancyMalignant Melanoma, Neoplasms
COMPLETED2 Analytics
PHASE1COMPLETED
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Malignant Melanoma, NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC)
Pre-dose and up to 168 hours post-dose
Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax)
Pre-dose and up to 168 hours post-dose
Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Time to maximum plasma concentration (Tmax)
Pre-dose and up to 168 hours post-dose
Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Terminal half-life (t1/2)
Pre-dose and up to 168 hours post-dose
Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Apparent clearance (CL/F)
Pre-dose and up to 168 hours post-dose

Secondary Endpoints

Safety: Incidence, nature and severity of adverse events (AEs) and serious AEs, graded according to NCI CTCAE Version 4.0
approximately 1.5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
A: phenprocoumon single doseACTIVE_COMPARATOR -
B: vemurafenib + phenprocoumon single doseEXPERIMENTAL -

Interventions

NameTypeDescription
phenprocoumonDRUG6 mg oral single dose
vemurafenibDRUG960 mg bid orally
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites17

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:BelgiumFinlandGermanyNetherlandsSpain
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Frequently asked questions about phenprocoumon

What is phenprocoumon used for?

Phenprocoumon is a small molecule being studied in oncology. It was evaluated in a Phase 1 clinical trial for patients with malignant melanoma and neoplasms, specifically those with BRAFV600 mutation-positive metastatic malignancy.

Who makes phenprocoumon?

Phenprocoumon is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored a Phase 1 clinical trial of the drug in oncology.

What phase is phenprocoumon in?

Phenprocoumon is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an active-controlled, randomized study. The drug is investigational and not approved for any use.

What clinical trials is phenprocoumon in?

Phenprocoumon was studied in clinical trial NCT01849666, titled "A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy." The trial enrolled 2 participants and was completed.

What does phenprocoumon target?

Phenprocoumon is a small molecule being studied in combination with vemurafenib in patients with BRAFV600 mutation-positive metastatic malignancy. The trial assessed how vemurafenib affects the pharmacokinetics of phenprocoumon in this patient population.

Was the phenprocoumon trial randomized?

Yes, the Phase 1 clinical trial of phenprocoumon was randomized and active-controlled. It was not double-blind. The study enrolled 2 patients aged 18 years and older with malignant melanoma or neoplasms.