A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2013 |
| Start Date: | July 2013 |
| End Date: | January 2015 |
| Contact: | Reference Study ID Number: GO28394 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. Only) |
A Phase I, Open-Label, Multicenter, 3-Period, Fixed-Sequence Study To Investigate The Effect Of Vemurafenib On The Pharmacokinetics Of A Single Dose Of Digoxin In Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
This open-label, multi-center, three-period, one sequence study will investigate the effect
of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable
BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a
V600-activating mutation of BRAF without acceptable standard treatment options. Patients
will receive multiple doses of vemurafenib in Periods B and C and a single dose of digoxin
in Periods A and C. Eligible patients will have the option to continue treatment with
vemurafenib as part of an extension study (NCT01739764). The anticipated time on study
treatment is approximately 36 days.
Inclusion Criteria:
- Male or female patients >= 18 years old
- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive
for the BRAFV600 mutation or other malignant tumor type that harbors a
V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600
mutation test or a DNA sequencing method, and who have no acceptable standard
treatment options
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Life expectancy >= 12 weeks
- Full recovery from the effects of any major surgery or significant traumatic injury
within 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 partners of
childbearing potential must agree to always use two effective methods of
contraception
- Negative serum pregnancy test within 7 days prior to commencement of dosing in women
of childbearing potential
Exclusion Criteria:
- Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose
of study drug
- Prior anti-cancer therapy within 28 days before the first dose of study drug
- History of clinically significant cardiac or pulmonary dysfunction
- History of symptomatic congestive heart failure of any New York Heart Association
class or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction within 6 months prior to first dose of study drug
- Current dyspnea at rest, owing to complications of advanced malignancy or any
requirement for supplemental oxygen to perform activities of daily living
- History of congenital long QT syndrome or QTc > 450 ms
- Current digoxin therapy or anticipated requirement to take digoxin therapy during the
study
- Active central nervous system lesions
- Uncontrolled or poorly controlled diabetes
- Current severe, uncontrolled systemic disease
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