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A Multi-center, Open-label, Study to Investigate the Pharmacokinetic Interaction of RO5185426 With a "Cocktail" of Five Probe Drugs for CYP450 Dependent Metabolism in Patients With Previously Treated and Untreated Metastatic Melanoma


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

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Trial Information

A Multi-center, Open-label, Study to Investigate the Pharmacokinetic Interaction of RO5185426 With a "Cocktail" of Five Probe Drugs for CYP450 Dependent Metabolism in Patients With Previously Treated and Untreated Metastatic Melanoma


Inclusion Criteria:



- Adult patient >/= 18 years of age

- Malignant melanoma (Stage IV, AJCC)

- Patients who are treatment-naive or have received prior systemic treatments for
metastatic melanoma. Time elapsed between previous treatment for metastatic disease
and first administration of study drug must be at least 28 days

- Positive tested for BRAF mutation

- Patients must not be poor metabolizers of CYP450 enzymes 2C9, 2C19, or 2D6 as
determined by genotyping

- Measurable disease by RECIST criteria

- Negative pregnancy test; for fertile men and women, effective contraception during
treatment and for 6 months after completion

Exclusion Criteria:

- Active CNS lesions on CT/MRI within 28 days prior to enrollment

- History of known spinal cord compression, or carcinomatous meningitis

- Severe cardiovascular disease within 6 months prior to study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics: blood concentration levels of RO5185426 and of the 5 drugs of the drug cocktail and their metabolites

Outcome Time Frame:

Multiple sampling, days 1-25

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:

NP22676

NCT ID:

NCT01001299

Start Date:

November 2009

Completion Date:

August 2013

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Fountain Valley, California  92708
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Boston, Massachusetts