EUCTR2009-015297-36-FR进行中（未招募）1 期
A Phase II (BRF113710) single-arm, open-label study of GSK2118436 in previously treated BRAF mutant metastatic melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the study treatment that may impact subject eligibility is provided in the IB [GlaxoSmithKline Document Number RM2009/000064/01].
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Has signed informed consent.
- •2. Histologically confirmed cutaneous metastatic melanoma (Stage IV), with BRAF mutation-positive (V600 E/K/D) melanoma as determined via central testing with a BRAF mutation assay.
- •3. Must have received at least one previous treatment for metastatic melanoma (i.e. chemotherapy, immunotherapy, prior targeted therapy, etc.).
- •4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [Eisenhauer, 2009].
- •5. Age ?18 years of age.
- •6. Able to swallow and retain oral medication.
- •7. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study (See Section 7.3.2).
- •8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 [Oken, 1982].
- •9. Must have adequate organ function as defined by the following baseline values:
- •Absolute neutrophil count (ANC) ?1.5x109/L
- •Hemoglobin ?9 g/dL
- •Platelets ?75x109/L
- •Serum bilirubin ?1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5xULN
- •Serum Creatinine ?1.5 mg/dL (If serum creatinine is >1.5 mg/dL, calculate creatinine clearance using standard Cockcroft and Gault method (refer to Section 12.4). Creatinine clearance must be > 50 mL/min.
- •Prothrombin time (PT)/International normalized ratio (INR) and partial thromboplastin time (PTT) ?1.3xULN
- •Left ventricular ejection fraction ? institutional lower limit of normal
- •10. Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment.
- •11. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study. Deviations from the exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
- •1. Previous treatment with a BRAF or MEK inhibitor.
- •2. Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
- •3. Current use of a prohibited medication or requires any of these medications during treatment with GSK2118436 (See Section 6.2).
- •4. Current use of therapeutic warfarin.
- •NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted.
- •5. Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) [NCI, 2009] Grade 2 or higher from previous anti-cancer therapy, except alopecia.
- •6. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK medical monitor for permission to enroll the subject.
- •7. A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection. Subjects with laboratory evidence of HBV clearance may be enrolled with permission of the GSK medical monitor.
- •8. A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •9. History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- •10. Presence of rheumatoid arthritis.
- •11. History or evidence of brain metastases on MRI.
- •12. The following cardiac abnormalities:
- •Corrected QT (QTc) interval ?480 msecs.
- •History of acute coronary syndromes (including unstable angina) within the past 24 weeks.
- •Coronary angioplasty, or stenting within the past 24 weeks.
- •Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- •Abnormal cardiac valve morphology (= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [ie, mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
- •History of known cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks.
- •Known cardiac metastases.
- •13. Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
- •14. Pregnant or lactating females.
研究者
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