EUCTR2013-004552-38-ES进行中（未招募）1 期
A Phase II, Multi-center, Open-label Study of sequential LGX818/MEK162 combination followed by a Rational Combination With targeted agents After Progression, to overcome resistance in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma - LOGIC 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients (males and females) age ? 18 years
- •Histologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IIIC to IV per American Joint Committee on Cancer [AJCC])
- •Documented evidence of BRAF V600 mutation.
- •Newly obtained tumor biopsy at baseline, and patient agrees to a mandatory biopsy at the time of progression, if not medically contraindicated.
- •Evidence of measurable disease, as determined by RECIST v1.1.
- •Inclusion criteria for triple combinations:
- •Progressive disease following prior treatment with LGX818/MEK162 combination.
- •A pre-LGX818/MEK162 combination archival tumor sample must be available
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Symptomatic or untreated leptomeningeal disease
- •Symptomatic brain metastases. Patients previously treated or untreated for brain metastases that are asymptomatic in the absence of corticosteroid therapy or on a stable dose of steroids for four weeks are allowed to enroll. Brain metastases must be stable at least 4 weeks with verification by imaging (e.g. brain MRI completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs.
- •Known acute or chronic pancreatitis.
- •History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes);
- •Clinically significant cardiac disease including any of the following:
- •CHF requiring treatment (NYH grade ? 2),
- •LVEF < 50% as determined by MUGA scan or ECHO
- •History or presence of clinically significant ventricular arrhythmias or atrial fibrillation
- •Clinically significant resting bradycardia
- •Unstable angina pectoris ? 3 months prior to starting study drug
- •Acute Myocardial Infarction (AMI) ? 3 months prior to starting study drug,
- •QTcF > 480 msec.
- •Patients with any of the following laboratory values at Screening/baseline:
- •Absolute neutrophil count (ANC) <1,500/mm3 [1.5 x 109/L]
- •Platelets < 100,000/mm3 [100 x 109/L]
- •Hemoglobin < 9.0 g/dL
- •Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% LLN (lower limit of normal)
- •Serum total bilirubin >1.5 x ULN
- •AST/SGOT or ALT/SGPT > 2.5 x ULN, or > 5 x ULN if liver metastases are present
- •Additional exclusion criteria for the triple combinations:
- •Patients who have developed brain metastases during Part I of the study may continue to Part II upon discussion with Sponsor Medical Monitor. The brain metastasis must be either asymptomatic or treated and stable for at least 4 weeks and on a stable or tapering dose of steroids for at least 2 weeks
- •Additional exclusion criteria for the triple combinations:
- •LGX818/MEK162/BKM120:
- •Patients with fasting glucose > 120 mg/dL or 6.7 mmol/L, and HbA1c > 8 %.
- •Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist:
- •Patient has a score ? 12 on the PHQ-9 questionnaire
- •Patient has ? CTCAE grade 3 anxiety
- •LGX818/MEK162/BGJ398:
- •History and/or current evidence of significant ectopic mineralization/ calcification with the exception of calcified lymph nodes and asymptomatic vascular calcification.
- •Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivits etc., confirmed by ophthalmologic examination
- •LGX818/MEK162/LEE011:
- •Patients with uncontrolled hypertension (please refer to WHO-ISH guidelines) are excluded from study.
- •QTcF >450 ms for males and >470 ms for females Congenital long QT syndrome or family history of unexpected sudden cardiac death and/or hypokalemia CTCAE Grade ? 3 and magnesium levels below the clinically relevant lower limits at study entry
- •Current evidence of brain metastasis or brain metastasis detected by mandatory CT/MRI at screening
- •PT/INR or aPTT > 1.5xULN
- •Asymptomatic serum amylase > CTCAE Grade 2 (1.5-2.0xULN). Patients with Grade 1 or Grade 2 serum amylase at the beginning of the study
- •must be confirmed to have no signs or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal im
研究者
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