EUCTR2014-003443-35-IT进行中（未招募）1 期
A Phase 2, multicenter, randomized, double-blind study of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic, EGFR-mutated non-small cell lung cancer (NSCLC) and BDX004 Positive Label
AVEO Pharmaceuticals0 个研究点目标入组 10 人开始时间: 2014年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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. Male or female and =18 years of age.
- •2. Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer staging criteria).
- •3. Measurable disease according to RECIST v.1.1.
- •4. An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.
- •5. BDX004 Positive Label.
- •6. Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or biologic therapy for metastatic NSCLC. Subjects may have previously been treated with postoperative adjuvant chemotherapy for early stage lung cancer or chemo-radiotherapy for locally advanced disease provided this was completed at least 6 months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •8. Clinical laboratory values meeting the following criteria prior to randomization:
- •Serum creatinine =1.5 x upper limit of normal (ULN).
- •Total bilirubin =1.5 x ULN.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN, or AST and ALT =5 x ULN if liver metastases.
- •Activated partial thromboplastin time (aPTT) =1.5 x ULN and prothrombin time/international normalized ratio (PT/INR) =1.5 x ULN if not on anticoagulation therapy. Subjects receiving anti-coagulation therapy with an agent such as warfarin or low-molecular weight heparin may be allowed to participate if the subject is on a stable dose of anticoagulant and coagulation test results are in the therapeutic range established prior to initiation of study treatment.
- •Hematologic function:
- •- Absolute neutrophil count (ANC) =1,500 cells/µL.
- •- Hemoglobin =9 g/dL or 5.6 mmol/L.
- •- Platelet count =100,000/µL.
- •9. For female subjects of childbearing potential, documentation of negative serum pregnancy test prior to randomization.
- •10. For female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 30 days after the last dose of study treatment. Effective birth control includes (a) intrauterine device plus one barrier method; (b) oral, implantable or injectable contraceptive plus one barrier method; or (c) two barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
- •11. Ability to give written informed consent and comply with protocol requirements
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or erlotinib.
- •2. History of known brain metastases.
- •3. Prior treatment with any other investigational drug or biologic agent within 5 half-lives prior to randomization, or any investigational device within 2 weeks prior to randomization.
- •4. Any unresolved toxicity from previous radiation therapy.
- •5. Significant cardiovascular disease, including:
- •Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left ventricular ejection fraction of less than 55%.
- •Cardiac failure New York Heart Association class III or IV.
- •Myocardial infarction, severe or unstable angina within 6 months prior to randomization.
- •History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation).
- •Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack). Catheter-related thrombosis is not a cause for exclusion. Diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred >3 months prior to randomization.
- •Any uncontrolled or severe cardiovascular disease.
- •6. Any other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial results.
- •7. History of prior malignancy within 3 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
- •8. Major surgery within 4 weeks prior to randomization.
- •9. Serious and/or symptomatic active infection within 14 days prior to first dose of study drug. Subjects who have asymptomatic or mild infection and are currently taking a short course of antibiotics (eg, urinary tract infection, bronchitis) may be allowed after discussion with the Medical Monitor.
- •10. Known human immunodeficiency virus infection.
- •11. Radiographic evidence of interstitial lung disease.
- •12. For female subjects, pregnancy or breast feeding.
研究者
相似试验
进行中（未招募）
不适用
A phase 2, double-blind, multicenter, randomized study comparing tenofovir disoproxil fumarate, emtricitabine plus tenofovir disoproxil fumarate, and entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease and in the prevention of hepatitis B recurrence post-transplantatioChronic Hepatitis B with decompensated liver diseaseMedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2005-004096-37-ITGilead Sciences Inc100
已完成
2 期
A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate CancerC61Malignant neoplasm of prostateProstatic NeoplasmsDRKS00003882Centocor, Inc.131
进行中（未招募）
不适用
A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate CancerHormone refractory prostate cancer (HRPC)MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerEUCTR2006-005766-39-DECentocor B.V.120
进行中（未招募）
不适用
A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate CancerHormone refractory prostate cancer (HRPC)MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerEUCTR2006-005766-39-ATCentocor B.V.120
已完成
2 期
A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate Cancer1/ Metastatic Hormono-resistant Prostate Cancer 2/ Metastatic HRPC10038588NL-OMON31063Janssen-Cilag20