A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01765569
First received: January 9, 2013
Last updated: August 26, 2014
Last verified: August 2014

January 9, 2013
August 26, 2014
July 2013
June 2014   (final data collection date for primary outcome measure)
  • Pharmacokinetics: Area under the concentration time curve [ Time Frame: Approximately 36 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum plasma concentration [ Time Frame: Approximately 36 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time to maximum plasma concentration [ Time Frame: Approximately 36 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Terminal half-life [ Time Frame: Approximately 36 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Apparent clearance [ Time Frame: Approximately 36 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01765569 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: Approximately 36 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
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 u nresectable BRAFV600-mutation positive metastatic melanoma or other malignant tu mor type that harbors a V600-activating mutation of BRAF without acceptable stan dard treatment options. Patients will receive multiple doses of vemurafenib in P eriods B and C and a single dose of digoxin in Periods A and C. Eligible patient s will have the option to continue treatment with vemurafenib as part of an exte nsion study (NCT01739764). The anticipated time on study treatment is approximat ely 36 days.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma, Neoplasms
  • Drug: digoxin
    Single dose of digoxin in Periods A and C
  • Drug: vemurafenib
    Multiple doses of vemurafenib in Periods B and C
  • Experimental: Digoxin treatment
    Intervention: Drug: digoxin
  • Experimental: Vemurafenib treatment
    Intervention: Drug: vemurafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   Israel,   Korea, Republic of,   Russian Federation,   South Africa
 
NCT01765569
GO28394, 2012-003459-13
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP