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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01849666
Other study ID # GO28398
Secondary ID 2012-003707-35
Status Completed
Phase Phase 1
First received May 3, 2013
Last updated November 1, 2016
Start date September 2013
Est. completion date April 2014

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
phenprocoumon
6 mg oral single dose
vemurafenib
960 mg bid orally

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  Finland,  Germany,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Safety: Incidence, nature and severity of adverse events (AEs) and serious AEs, graded according to NCI CTCAE Version 4.0 approximately 1.5 years No
See also
  Status Clinical Trial Phase
Completed NCT01844674 - A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies Phase 1
Withdrawn NCT01765556 - A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma Phase 1
Completed NCT01765543 - A Pharmacokinetics Study to Investigate the Effect of Rifampin on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy Phase 1
Completed NCT01765569 - A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma Phase 1
Completed NCT01851824 - A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy Phase 1