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A Phase I, Open-Label, Multicenter, Three-Period, One-Sequence Study To Investigate The Effect Of Rifampin On The Pharmacokinetics Of A Single Oral Dose Of 960 Mg Of Vemurafenib


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma, Neoplasms

Thank you

Trial Information

A Phase I, Open-Label, Multicenter, Three-Period, One-Sequence Study To Investigate The Effect Of Rifampin On The Pharmacokinetics Of A Single Oral Dose Of 960 Mg Of Vemurafenib


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 cobasĀ® 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

- Requirement for immediate or urgent treatment with daily vemurafenib and for whom the
intermittent schedule of vemurafenib employed during the 24-day period for this trial
is not clinically acceptable

- Allergy or hypersensitivity to components of the vemurafenib formulation

- Experimental therapy within 4 weeks prior to first dose of study drug

- Major surgical procedure or significant traumatic injury within 14 days prior to
first dose of study drug or anticipation of the need for major surgery during study
treatment

- 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

- Active central nervous system lesions

- Uncontrolled or poorly controlled diabetes

- Current severe, uncontrolled systemic disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics: Area under the concentration time curve

Outcome Time Frame:

Approximately 24 days

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:

GO28052

NCT ID:

NCT01765543

Start Date:

April 2013

Completion Date:

October 2014

Related Keywords:

  • Malignant Melanoma, Neoplasms
  • Neoplasms
  • Melanoma

Name

Location

Fountain Valley, California  92708
Cleveland, Ohio  44195
Austin, Texas  78705
Little Rock, Arkansas  72205-7199