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An Open-label, Pilot Study of RO5185426 in Previously Treated Metastatic Melanoma Patients With Brain Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

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Trial Information

An Open-label, Pilot Study of RO5185426 in Previously Treated Metastatic Melanoma Patients With Brain Metastases


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation
(cobas 4800 BRAF V600 Mutation Test)

- Brain metastases for which surgical resection is not a treatment option

- Patients must have failed at least one previous treatment for brain metastases

- Requiring corticosteroids for symptom control

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

- Increasing corticosteroid dose during the 7 days prior to study entry

- Previous malignancy within the past 2 years, except for basal or squamous cell
carcinoma of the skin or carcinoma in-situ of the cervix

- Concurrent administration of any anticancer therapies other than those administered
in the study

- Clinically significant cardiovascular disease or event within the 6 months prior to
first dose of study drug

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:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 9 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Switzerland: Swissmedic

Study ID:

MO25653

NCT ID:

NCT01253564

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Melanoma
  • Neoplasm Metastasis

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