Skip to main content
MedPathMedPath Home
Clinical Trials/PER-001-12
PER-001-12
Unknown
未知

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

F. HOFFMANN-LA ROCHE LTD.,0 sites5 target enrollmentMarch 28, 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
F. HOFFMANN-LA ROCHE LTD.,
Enrollment
5
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 28, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Access Program for Asfotase Alfa
EUCTR2015-000809-39-FRAlexion Pharma International Sàrl100
Completed
Not Applicable
Trastuzumab deruxtecan for subjects with HER2 mutated metastatic NSCLC
JPRN-jRCT2071220096eno Shizuko30
Active, not recruiting
Not Applicable
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
Active, not recruiting
Phase 1
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
Active, not recruiting
Not Applicable
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