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A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

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

NCT01253564•Hoffmann-La Roche

Summary

This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

CHUV; Departement d'Oncologie

Lausanne, Switzerland

Universitätsspital Zürich; Dermatologische Klinik

Zurich, Switzerland

Key Dates

Start Date

November 22, 2010

Primary Completion Date

March 14, 2012

Completion Date

March 14, 2012

Last Updated

July 31, 2017

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

RO5185426

DRUG

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

AMT-253 in Patients With Advanced Solid Tumours

Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract

Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery

Registry of Subjects at Risk of Pancreatic Cancer