None listed
Conditions
Interventions
PATIENTS WILL RECEIVE CONTINUOUS ORAL DOSES OF RO5185426 960 MG TWICE A DAY (B.I.D.) STARTING ON DAY 1 OF THE STUDY TREATMENT PHASE UNTIL THE DEVELOPMENT OF PROGRESSIVE DISEASE (AS PER INVESTIGATOR AS
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.- MALE OR FEMALE PATIENTS ≥ 16 YEARS OF AGE 2.- 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. 3.- PATIENTS WITH EITHER MEASURABLE OR NON-MEASURABLE DISEASE (RECIST VERSION 1.1) 4.- PATIENTS MAY OR MAY NOT HAVE RECEIVED PRIOR SYSTEMIC THERAPY FOR METASTATIC MELANOMA 5.- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS (PS) OF 0-2 6.- PATIENTS MUST HAVE RECOVERED FROM ALL SIDE EFFECTS OF THEIR MOST RECENT SYSTEMIC OR LOCAL TREATMENT FOR METASTATIC MELANOMA 7.- 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) ≥ 1.5x10(ninth)/L - PLATELET COUNT ≥ 100x10(ninth)/L - HEMOGLOBIN ≥ 9G/DL - SERUM CREATININE ≤ 1.5 TIMES UPPER LIMIT OF NORMAL (ULN) OR CREATININE CLEARANCE (CrCl) > 50 mL/hr BY COCKROFT-GAULT FORMULA - ASPARTATE AMINOTRANSFERASE (AST [SGOT]) AND ALANINE AMINOTRANSFERASE (ALT [SGTP]) ≤ 2.5 TIMES ULN (≤ 5 TIMES ULN IF CONSIDERED DUE TO TUMOR) - SERUM BILIRUBIN ≤ 1.5 TIMES ULN - ALKALINE PHOSPHATASE ≤ 2.5 TIMES ULN (≤ 5 TIMES ULN IF CONSIDERED DUE TO TUMOR) 8.- NEGATIVE SERUM PREGNANCY TEST WITHIN 7 DAYS PRIOR TO COMMENCEMENT
Exclusion criteria
Exclusion criteria: 1.- EVIDENCE OF SYMPTOMATIC CNS LESIONS AS DETERMINED BY INVESTIGATOR (PATIENTS WITH RADIOGRAPHICALLY STABLE, ASYMPTOMATIC LESIONS PREVIOUSLY IRRADIATED OR SURGICALLY RESECTED ARE ELIGIBLE) 2.- 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. 3.- CONCURRENT ADMINISTRATION OF ANY ANTI-CANCER THERAPIES (E.G. CHEMOTHERAPY, OTHER TARGETED THERAPY, EXPERIMENTAL DRUG, ETC.) OTHER THAN THOSE ADMINISTERED IN THIS STUDY 4.- KNOWN HYPERSENSITIVITY TO RO5185426 OR ANOTHER BRAF INHIBITOR 5.- PREGNANT OR LACTATING WOMEN 6.- REFRACTORY NAUSEA AND VOMITING, MALABSORPTION, EXTERNAL BILIARY SHUNT, OR SIGNIFICANT BOWEL RESECTION THAT WOULD PRECLUDE ADEQUATE ABSORPTION. PATIENTS MUST BE ABLE TO SWALLOW TABLETS. 7.- 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. 8.- HISTORY OF CONGENITAL LONG QT SYNDROME, HISTORY OR PRESENCE OF CLINICALLY SIGNIFICANT VENTRICULAR OR ATRIAL DYSRHYTHMIAS ≥ GRADE 2 (NCI CTACAE VERSION 4.0) 9.- CORRECTED QT
Countries
Albania, Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea South, Lithuania, Macedonia, Mexico, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kindgdom
Contacts
Public ContactANGELO MIGUEL STORACE
ROCHE FARMA (PERU) S.A.
Outcome results
None listed