A 2-part phase III randomized, open label, multicenter study of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in patients with unresectable or metastatic BRAF V600 mutant melanoma - COLUMBUS

Array BioPharma Inc.0 个研究点目标入组 900 人开始时间: 2013年8月14日最近更新: 2017年11月13日

适应症

试验速览

暂无简介。

•-Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC Stage IIIB,IIIC, or IV)
•-Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to randomization
•-Naïve untreated patients OR PATIENTS WHO HAVE PROGRESSED ON OR AFTER PRIOR IRST-LINE IMMUNOTHERAPY for unresectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy or radiotherapy), EXCEPT THE
•ADMINISTRATION OF BRAF OR MEK INHIBITORS.
•-Evidence of at least one measurable lesion as detected by radiological
•or photographic methods
•-ECOG performance status of 0 or 1
•-Adequate bone marrow, organ function, cardiac and laboratory
•-Normal functioning of daily living activities
•-Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 675
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 225

•- Any untreated/non-stable brain lesion
•- Mucosal or uveal melanoma
•- History of leptomeningeal metastases
•- HISTORY OF OR CURRENT EVIDENCE OF RETINAL VEIN OCCLUSION (RVO).
•- Ipilimumab or other immunotherapy treatment must have ended at least 6 weeks prior to randomization.
•- Any previous SYSTEMIC CHEMOTHERAPY treatment, extensive radiotherapy or investigational agent OTHER THAN IMMUNOTHERAPY, OR PATIENTS WHO HAVE RECEIVED MORE THAN ONE LINE OF IMMUNOTHERAPY for locally advanced unresectable or metastatic melanoma
•- History of Gilbert's syndrome
•- Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
•- Impaired cardiovascular function or clinically significant cardiovascular diseases
•- Uncontrolled arterial hypertension despite medical treatment
•- HIV positive or active Hepatitis B, and/or active Hepatitis C
•- Impairment of gastrointestinal function or gastrointestinal disease
•- Patients with neuromuscular disorders that are associated with elevated CK.
•- Pregnant or nursing (lactating) women
•- PATIENTS TAKING NON-TOPICAL MEDICATION KNOWN TO BE A STRONG INHIBITOR OF CYP3A4
•- Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
•Other protocol-defined exclusion criteria may apply

发起方