Clinical trial · Interventional
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
A PHASE I, OPEN-LABEL, MULTICENTER, RANDOMINZED, PARALELL STUDY TO INVESTIGATE THE EFFECT OF VEMURAFENIB ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF PHENPROCOUMON IN PATIENTS WITH BRAFV600 MUTATION-POSITIVE METASTATIC MALIGNANCY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label, multicenter, parallel study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in the extension study after completion of pharmacokinetic assessments).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma, Neoplasms | Melanoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| phenprocoumon | Drug | — | UNRESOLVED |
| vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: phenprocoumon single dose
- interventionNames
- Drug: phenprocoumon
- type
- EXPERIMENTAL
- label
- B: vemurafenib + phenprocoumon single dose
- interventionNames
- Drug: vemurafenib
Primary outcomes (5)
- measure
- Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC)
- timeFrame
- Pre-dose and up to 168 hours post-dose
- measure
- Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 Group (ECOG) performance status 0 to 2 * Full recovery from any major surgery or significant traumatic injury at least 14 days prior to the first dose of study treatment * Adequate hematologic and end organ function * Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 effective methods of contraception as defined by protocol during the course of the study and for at least 6 months after completion of study treatment Exclusion Criteria: * Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1 * Prior anti-cancer therapy within 28 days (6 weeks for nitrosureas or mitocyn C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment Day 1 * Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1 * Experimental therapy within 4 weeks prior to first dose of study treatment Day 1 * History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/=2 hypertension or unstable angina * Current Grade \>/=2 dyspnea or hypoxia or need for oxygen supplementation * History of myocardial infarction within 6 months prior to first dose of study treatment * Active central nervous system lesions (i.e. patients with radiographically unstable, symptomatic lesions) * History of bleeding or coagulation disorders * Allergy or hypersensitivity to vemurafenib or phenprocoumon formulations * History of malabsorption or other condition that would interfere with the enteral absorption of study treatment * History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection * Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness * Pregnant or lactating women
References
Publications (0)
Data not yet available