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A PHASE I, OPEN-LABEL, MULTICENTER, 3-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF VEMURAFENIB ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF ACENOCOUMAROL IN PATIENTS WITH BRAFV600 MUTATION-POSITIVE METASTATIC MALIGNANCY


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Malignant Melanoma, Neoplasms

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Trial Information

A PHASE I, OPEN-LABEL, MULTICENTER, 3-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF VEMURAFENIB ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF ACENOCOUMAROL IN PATIENTS WITH BRAFV600 MUTATION-POSITIVE METASTATIC MALIGNANCY


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 acenocoumarol 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Pharmacokinetics of single-dose acenocoumarol under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC)

Outcome Time Frame:

Pre-dose and up to 72 hours post-dose

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

GO28397

NCT ID:

NCT01851824

Start Date:

May 2013

Completion Date:

April 2014

Related Keywords:

  • Malignant Melanoma, Neoplasms
  • Neoplasms
  • Melanoma

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