跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/PER-001-12
PER-001-12未知未知

AN OPEN-LABEL, MULTICENTER EXPANDED ACCESS STUDY OF RO5185426 IN PATIENTS WITH METASTATIC MELANOMA

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 5 人开始时间: 2012年3月28日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
未知
入组人数
5
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
16 至 99（—）

入选标准

  • •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

排除标准

  • •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

研究者

相似试验

进行中（未招募）
1 期
Access Program for Asfotase AlfaHypophosphatasia
EUCTR2015-000809-39-FRAlexion Pharma International Sàrl100
已完成
Unknown
Trastuzumab deruxtecan for subjects with HER2 mutated metastatic NSCLC
JPRN-jRCT2071220096eno Shizuko30
进行中（未招募）
不适用
An expanded access program of ranibizumab in patients with visual impairment due to diabetic macular edema for whom no suitable therapeutic alternatives exist.
EUCTR2011-002731-26-ITOVARTIS FARMA700
进行中（未招募）
1 期
An open-label, multicenter, expanded access study of imatinib mesylate in adult patients with GIST in adjuvant setting after R0-resectiogastrointestinal stromal tumors - adjuvant treatment after surgical tumor resectionMedDRA version: 9.1Level: LLTClassification code 10051066Term: Gastrointestinal stromal tumour
EUCTR2008-003883-20-CZovartis Pharma GmbH
进行中（未招募）
不适用
An open-label, multicenter, expanded access study of imatinib mesylate in adult patients with GIST in adjuvant setting after R0-resectiogastrointestinal stromal tumors - adjuvant treatment after surgical tumor resectionMedDRA version: 9.1Level: LLTClassification code 10051066Term: Gastrointestinal stromal tumour
EUCTR2008-003883-20-DEovartis Pharma GmbH750