EUCTR2012-004743-68-FR进行中（未招募）1 期
A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients with Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
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
- •1. Aged =18 years at the time of signing the informed consent.
- •2. Histologically confirmed diagnosis of NSCLC, advanced (stage IIIB) or metastatic (stage IV).
- •3. Documented somatic ErbB2 (HER2) activating mutation.
- •4. Patients with anaplastic lymphoma kinase (ALK) translocations must have received crizotinib, except for cases of intolerable toxicity to crizotinib.
- •5. Documented progressive disease by radiographic study following at least one prior cytotoxic chemotherapy regimen, or withdrawal from prior treatment due to documented toxicity.
- •6. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- •7. Eastern Cooperative Oncology Group (ECOG) status <2.
- •8. Left ventricular ejection fraction (LVEF) =50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).
- •9. Negative ß-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.
- •10. Men and women of childbearing potential must agree and commit to the use of a highly effective method of contraception, as determined to be acceptable by the Investigator, from the time of informed consent until 3 months after the last dose of the investigational products.
- •11. Provide written, informed consent to participate in the study and follow the study procedures.
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Previous treatment with any investigational agent =30 days prior to the initiation of investigational products.
- •2. Previous treatment with any strong inhibitor and/or inducer of CYP3A4 enzyme or sensitive P-glycoprotein (P gp) substrates =30 days prior to the initiation of investigational products.
- •3. Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of =2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.
- •4. Major surgery <30 days of starting treatment.
- •5. Chronic steroid use (prednisone >12.5 mg/day or dexamethasone >2 mg/day, excluding inhaled steroids).
- •6. Currently breast feeding.
- •7. Symptomatic or unstable brain metastases.
- •8. QTc interval >0.450 seconds or known history of QTc prolongation or Torsades de Pointes (TdP).
- •9. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or Grade =2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline).
- •10. Prior exposure to tyrosine kinase inhibitor including neratinib, lapatinib, and afatinib (excluding dacomitinib), or mTOR inhibitor.
- •11. Active infection or unexplained fever >38.5°C (101.3°F).
- •12. Unable or unwilling to swallow tablets.
- •13. Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator’s judgment, make the patient inappropriate for this study.
- •14. Known hypersensitivity to any component of the investigational products.
- •15. Unstable or uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c] >6.5%).
- •16. Screening laboratory assessments outside the following limits:
- •Laboratory endpoint : Required limit for exclusion
- •Absolute neutrophil count (ANC) : <1500/mL (1.5 x 10e9/L)
- •Platelet count : <75,000/mL
- •Hemoglobin (Hb) : <8 g/dL (transfusions allowed) Transfusions must be at least 14 days prior to baseline.
- •Total bilirubin : >1.5 x institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST)
- •and/or Alanine aminotransferase (ALT) : >2.5 x institutional ULN (>5 x ULN if liver metastases are present)
- •Creatinine clearance : <50 mL/min (as calculated by Cockroft-Gault formula or Modification of Diet in Renal Disease [MDRD] formula)
- •Serum lipids : Fasting serum cholesterol >9.0 mmol/L (>350 mg/dL), fasting triglycerides >4.56 mmol/L (>400 mg/dL)
- •Serum calcium (corrected for albumin level) : >1.0 x ULN.
研究者
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