EUCTR2011-000874-67-IT
Active, not recruiting
Not Applicable
An open-label, multicenter, single-arm, Phase I dose-escalation withefficacy tail extension study of RO5185426 in pediatric patients withsurgically incurable and unresectable Stage IIIC or Stage IV melanomaharboring BRAFV600 mutations
ConditionsMetastatic MelanomaMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Melanoma
- Sponsor
- ROCHE
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with histologically confirmed surgically incurable and
- •unresectable stage IIIC or stage IV (AJCC) melanoma. Unresectable
- •stage IIIC disease must have confirmation from a surgical oncologist.
- •2\.Patients must have a positive BRAF mutation result determined by a Roche\-designated central reference laboratory using the cobas 4800
- •BRAF V600 Mutation Test prior to administration of RO5185426\.
- •3\.Patients may have newly diagnosed melanoma or have completed and
- •failed prior standard of care regimen (e.g., DTIC, temozolomide, etc.).
- •4\.Measurable disease according to RECIST criteria Version 1\.1
- •5\. Must have a head CT/MRI to evaluate for CNS metastasis within 28
- •days prior to treatment. Patients with radiographically stable,
Exclusion Criteria
- •2\.History of or known spinal cord compression, or carcinomatous
- •meningitis.
- •3\.Negative result for BRAF mutation as determined using the Roche
- •cobas 4800 BRAF V600 Mutation Test
- •4\.Anticipated or ongoing administration of anti\-cancer therapies other
- •than those administered in this study.
- •5\.Patients with a previous malignancy within the past 5 years are
- •excluded except for patients with basal or squamous cell carcinoma
- •(SCC) of the skin, melanoma in\-situ, and carcinoma in\-situ of the cervix.
- •6\.Patients who have been previously treated with a selective/specific
Outcomes
Primary Outcomes
Not specified
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