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An Open Label, Phase I Study to Evaluate the Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation Positive Cancer Patients

Phase 1
18 Years
Open (Enrolling)

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Trial Information

An Open Label, Phase I Study to Evaluate the Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation Positive Cancer Patients

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically confirmed BRAF V600 mutation-positive advanced solid malignancy that
is metastatic or unresectable and for which standard curative or palliative measures
do not exist or are no longer effective

- Normal or impaired hepatic function (hepatic function will be classified according to
the NCI Organ Dysfunction Working Group criteria)

- For patients with hepatic impairment: Stable hepatic function for at least 2 weeks
before Day 1

- Eastern Cooperative Oncology Group (ECOG) performance status of
- Patients with a history of recent brain metastases must have completed any radiation
therapy at least 4 weeks before Day 1, be without intervening signs of brain lesion
progression and not require steroids before starting the protocol (Day 1). Patients
with gliomas or known brain metastases who require anticonvulsants must be seizure
free for 1 month prior to enrollment

- Life expectancy > 8 weeks

- Adequate hematologic and renal function

- Females patients of childbearing potential and male patients with female partners of
childbearing potential must agree to use two adequate methods of contraception as
defined by protocol during the course of this study and for at least 6 months after
completion of study treatment

Exclusion Criteria:

- Allergy or hypersensitivity to components of the vemurafenib formulation

- Requirement for immediate or urgent treatment with vemurafenib and for whom the
intermittent schedule of vemurafenib employed during Days 1-26 in this trial is not
clinically acceptable

- Chemotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior
to entering the study, or those who have not recovered from AEs because of agents
administered more than 4 weeks earlier

- Gliomas or known brain metastases that require corticosteroids

- History of clinically significant cardiac or pulmonary dysfunction

- HIV-positive patient requiring antiviral treatment including protease inhibitors

- Active infection or chronic infection requiring chronic suppressive antibiotics

- Pregnancy or breastfeeding at Day 1

- History of malabsorption or other clinically significant metabolic dysfunction

- Active autoimmune disease

- Current, recent (within 28 days prior to Day 1), or planned use of any
investigational product outside this study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-normalized area under the concentration-time curve (AUC) during the dose interval on Day 20 (steady state)

Outcome Time Frame:

Pre-dose and up to 168 hours after the morning dose Day 20

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

July 2019

Related Keywords:

  • Neoplasms
  • Neoplasms
  • Liver Diseases



Fountain Valley, California  92708