NL-OMON47136招募中不适用
A phase Ib/II multi-center, open-label, dose escalation study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in patients with BRAF mutant metastatic colorectal cancer. - LGX818 combination therapy in BRAF mutant colorectal cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
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
- 18 至 99（—）
入选标准
- •1. Histological or cytological proof of metastatic colorectal cancer (mCRC)
- •2. Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
- •3. KRAS wild-type and BRAF V600E mutation, or any other BRAF V600 mutation
- •4. Phase II only: fresh tumor biopsy at baseline
- •5. Evidence of measurable disease, as determined by RECIST v1.1.
- •6. Life expectancy >= 3 months
- •7. ECOG performance status <= 2
- •Protocol amendment 4: Inclusion criteria 7: ECOG performance status <= 1
排除标准
- •1. Phase II only: previous treatment with cetuximab, panitumumab, other EGFR inhibitors, RAF-inhibitors, PI3K-inhibitors, and/or MEK-inhibitors
- •2. Symptomatic or untreated leptomeningeal disease
- •3. Symptomatic brain metastasis.
- •4. Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose >=7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
- •5. Known acute or chronic pancreatitis
- •6. Clinically significant cardiac disease including any of the following:
- •Congestive heart failure requiring treatment (NYHA grade >= 2), LVEF < 45%), 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, Aacute Myocardial Infarction (AMI) <= 3 months prior to starting study drug, QTcF > 480 msec
- •7. Any of the following laboratory values at Screening/baseline:
- •Absolute neutrophil count (ANC) <1.5 x 109/L
- •Platelets < 100 x 109/L
- •Hemoglobin < 5,58 mmol/L
- •Serum creatinine >1.5 x ULN or Creatinin Clearance < 50% LLN (lower limit of normal)
- •Serum total bilirubin >1.5 x ULN, except for patients with Gilbert*s syndrome, who may be included if total bilirubin is <= 3.0 x ULN and direct bilirubin is <= 1.5 x ULN
- •AST/SGOT and/or ALT/SGPT > 2.5 x ULN, or > 5 x ULN if liver metastases are present
- •8. Impairment of gastrointestinal (GI) function or GI disease which may alter the absorption of LGX818
- •9. Previous or concurrent malignancy. Exceptions: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
- •10. Pregnant or nursing (lactating) women
- •11. History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, deep vein thrombosis, or pulmonary embolism.
- •12. Radiation therapy (> 30% of the bone marrow reserve), chemotherapy, biological therapy (e.g., antibodies) within <= 4 weeks
- •13. Any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery
- •14. Known human immunodeficiency virus (HIV) infection
- •15. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results
研究者
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