A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
NCT ID: NCT01253564
Last Updated: 2017-07-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2010-11-22
2012-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of RO5185426 in Patients With Metastatic Melanoma
NCT01248936
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
NCT01164891
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
NCT05419388
A Study of Vemurafenib in Participants With Metastatic Melanoma
NCT01307397
Intratumoral Application of L19IL2 in Patients With Malignant Melanoma
NCT01253096
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Arm
RO5185426
960 mg b.i.d. orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RO5185426
960 mg b.i.d. orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHUV; Departement d'Oncologie
Lausanne, , Switzerland
Universitätsspital Zürich; Dermatologische Klinik
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MO25653
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.