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acenocoumarol · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Acenocoumarol + Vemurafenib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| acenocoumarol | DRUG | 4 mg single oral doses on Days 1 and 23 |
| vemurafenib | DRUG | 960 mg orally bid, 20 days (Days 4-23) |
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 ...
Acenocoumarol is a small molecule drug developed by Roche Holding AG (ticker RHHBY). It has been studied in oncology, specifically in patients with malignant melanoma and other neoplasms. It is an investigational agent in Phase 1 development and is not described as approved.
Acenocoumarol targets VKORC1 and acts as an inhibitor of that target. VKORC1 is the enzyme targeted by vitamin K antagonist anticoagulants. In the oncology setting studied, acenocoumarol was evaluated for its pharmacokinetic interaction with vemurafenib in patients with BRAFV600 mutation-positive metastatic malignancy.
Roche Holding AG, which trades under the ticker RHHBY, is the developer of acenocoumarol. Roche sponsored the clinical study of the drug in patients with BRAFV600 mutation-positive metastatic malignancy.
Acenocoumarol is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and is not described as FDA approved for any indication.
Acenocoumarol has been studied in one completed Phase 1 trial, NCT01851824, titled A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy. It enrolled 9 patients across Australia, Germany, Greece, Hungary, the Netherlands, New Zealand, Portugal, Serbia and Spain.
Acenocoumarol was studied in patients with malignant melanoma and other neoplasms who had BRAFV600 mutation-positive metastatic malignancy. The completed Phase 1 trial examined the effect of vemurafenib on acenocoumarol pharmacokinetics. The study was uncontrolled, non-randomized, and enrolled 9 patients aged 18 years and older.