An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanoma

F. Hoffmann-La Roche Ltd.0 sites3,300 target enrollmentOctober 6, 2011

ConditionsPatients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.MedDRA version: 17.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsZelboraf 240 mg Film-coated Tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.
Sponsor: F. Hoffmann-La Roche Ltd.
Enrollment: 3300
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

October 6, 2011

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche Ltd.

Eligibility Criteria

Inclusion Criteria

•\- Male or female patients \=16 years of age
•\- Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® 4800 BRAF V600 Mutation Test prior to
•administration of RO5185426\. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
•\- Patients with either measurable or non\-measurable disease (RECIST Version 1\.1\)
•\- Patients may or may not have received prior systemic therapy for metastatic melanoma
•\- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0\-2
•\- Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
•\- Adequate hematologic, renal and liver function as defined by the following laboratory values performed within 7 days prior to first dose of RO5185426:
•Absolute neutrophil count (ANC) \= 1\.5 x 109/L
•Platelet count \= 100 x 109/L

Exclusion Criteria

•\- Evidence of symptomatic CNS lesions as determined by investigator, use of steroids or anti\-seizure medications for the treatment of brain metastases prior to the first administration of RO5185426\. Patients with asymptomatic lesions previously irradiated or surgically resected that are radiologically stable are eligible. Patients with incidentally found brain metastasis that are asymptomatic and for which no treatment is planned are also eligible
•\- Patients with a previous malignancy (other than melanoma) within the past 2 years are excluded except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in\-situ of the cervix. Isolated
•elevation in prostate\-specific antigen in absence of
•radiographic evidence of metastatic prostate cancer is allowed
•\- Concurrent administration of any anti\-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc) other than those administered in this study
•\- Known hypersensitivity to RO5185426 or another BRAF inhibitor
•\- Pregnant or lactating women
•\- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption. Patients must be able to swallow tablets
•\- Any of the following within the 6 months prior to first RO5185426 administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications
•\- History of congenital long QT syndrome, history or presence of clinically significant ventricular or atrial dysrhythmias \= Grade 2 (NCI CTCAE Version 4\.0\)