An open-label, multicenter, single-arm, Phase I dose-escalation with efficacy tail extension study of vemurafenib (RO5185426) in pediatric patients with surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations - NA

F. Hoffman-La Roche Ltd.0 sites20 target enrollmentAugust 17, 2011

ConditionsMetastatic Melanoma MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Melanoma
Sponsor: F. Hoffman-La Roche Ltd.
Enrollment: 20
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 17, 2011

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffman-La Roche Ltd.

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 vemurafenib.
•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, asymptomatic previously treated lesions are eligible provided:
•\-Patient has received prior treatment \[including radiation therapy (whole brain radiotherapy is not allowed with the exception of patients who have also had definitive resection or stereotactic therapy of all radiologically detectable parenchymal lesions), stereotactic radiosurgery, surgical resection] to the site(s) of CNS metastatic disease \= 3 months prior to starting study treatment
•\-Patient has no requirement for glucocorticoids, and discontinued \= 21 days prior to starting study treatment
•\- Patient is not taking anticonvulsants (discontinued at least 3 weeks prior to treatment)
•6\.Patients aged \= 12 to \= 17 years
•7\.Performance Status: Karnofsky performance score of 50\-100 (for patients \=16 years of age) or Lansky score of \= 60 (for patients \< 16 years of age)

Exclusion Criteria

•1\.Patients with active or untreated CNS lesions
•2\.History of or known spinal cord compression, or carcinomatous meningitis.
•3\.Negative result for BRAF mutation as determined using the 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 BRAF or MEK inhibitor (previous treatment with sorafenib is allowed).
•7\.Patients who have had any previous treatment with study drug (vemurafenib) or participated in a clinical trial that includes vemurafenib.
•8\.QTc \>450 msec on screening ECG or history of congential long QT syndrome.
•9\.NCI\-CTCAE Version 4\.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
•10\.Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident or transient ischemic attack, or