STUDY TO ASSESS THE SAFETY OF RO5185426 IN PATIENTS WITH METASTATIC MELANOMA
- Registration Number
- PER-001-12
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 5
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method