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phenprocoumon · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A: phenprocoumon single dose | ACTIVE_COMPARATOR | - |
| B: vemurafenib + phenprocoumon single dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| phenprocoumon | DRUG | 6 mg oral single dose |
| vemurafenib | DRUG | 960 mg bid orally |
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 ...
Phenprocoumon is being studied in patients with BRAFV600 mutation-positive metastatic malignancy, including malignant melanoma and other neoplasms. In this setting it is used as a probe to assess how the anticancer agent vemurafenib affects its pharmacokinetics. It is not an anticancer therapy itself in this program.
Phenprocoumon targets VKORC1, the vitamin K epoxide reductase complex subunit 1. It acts as an inhibitor of this enzyme, which is the same target engaged by warfarin-type anticoagulants. This mechanism underlies its established role as an oral anticoagulant and its use as a pharmacokinetic probe in the vemurafenib interaction study.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with the phenprocoumon clinical program described here. The compound itself has a long history as an oral anticoagulant, and Roche sponsored the Phase 1 drug interaction study in patients with BRAFV600 mutation-positive metastatic malignancy.
Phenprocoumon is in Phase 1 development for malignant melanoma and neoplasms. The single recorded trial, NCT01849666, is a completed Phase 1 study. It is an investigational use in oncology, and the program is not currently recruiting, with no active trials listed.
Phenprocoumon has been evaluated in one 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 Phase 1 study is completed, enrolled 2 participants, was randomized and active-controlled, and ran in Belgium, Finland, Germany, the Netherlands, and Spain.