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临床试验/EUCTR2010-021082-74-LT
EUCTR2010-021082-74-LT进行中（未招募）不适用

RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND PHASE 1B/2 STUDY OF U3-1287 (AMG 888) IN COMBINATION WITH ERLOTINIB IN EGFR TREATMENT NAÏVE SUBJECTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON AT LEAST ONE PRIOR CHEMOTHERAPY

DAIICHI SANKYO DEVELOPMENT LTD.0 个研究点目标入组 210 人开始时间: 2010年12月28日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
210
研究概览入排标准研究者记录与标识符相似试验

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. Men or women = 18 years old.
  • •2. Histologically or cytologically confirmed NSCLC
  • •with either:
  • •- Metastatic disease (Stage IV) OR
  • •- Stage IIIB disease not amenable to surgery or curative intent.
  • •3. Disease progression or recurrence following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months) documented by radiographic assessment.
  • •4. Measurable disease per RECIST guidelines Version 1.1.
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • •6. Hematological function, as follows:
  • •- Absolute neutrophil count (ANC) = 1.5 × 10e9/L
  • •- Platelet count = 100 × 10e9/L
  • •- Hemoglobin = 9 g/dL.
  • •7. Renal function, as follows:
  • •- Calculated creatinine clearance = 60 mL/min using the modified Cockroft-Gault equation or serum creatinine = 1.5 x ULN.
  • •8. Hepatic function, as follows:
  • •- Aspartate aminotransferase (AST) = 2.5 ×upper limit of normal (ULN) (if liver
  • •metastases are present, < 5 × ULN)
  • •- Alanine aminotransferase (ALT) = 2.5 ×ULN (if liver metastases are present,
  • •< 5 × ULN)
  • •- Alkaline phosphatase = 2.5 × ULN (if bone or liver metastases are present, < 5 × ULN)
  • •- Bilirubin = 1.5 × ULN.
  • •9. Prothrombin time (PT) and partial thromboplastin time (PTT) = 1.5 × ULN.
  • •10. Availability of recent (before treatment start) or archival (does not have to be provided by treatment start) tumor specimen (Phase 2 subjects only).
  • •11. For female subjects, must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile, or must use maximally effective birth control during the period of therapy, and be willing to use contraception for 6 months following the last investigational drug dose and have a negative urine or serum pregnancy test upon entry into this study if female subjects of childbearing
  • •12. For male subjects, must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last investigational drug dose.
  • •13. Subjects must be competent and able to comprehend, sign, and date an Independent Ethics Committee- or Institutional Review Board-approved
  • •Informed Consent Form (including Health Insurance Portability and Accountability Act
  • •authorization, if applicable) before performance of any study-specific procedures or tests.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 3
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 9

排除标准

  • •1. Left ventricular ejection fraction (LVEF) < 45%.
  • •2. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy.
  • •3. More than 2 prior chemotherapy regimens for this indication (Phase 2 subjects only).
  • •4. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for = 5 years.
  • •5. History of corneal disease.
  • •6. History of interstitial lung disease.
  • •7. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and require no reatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks (2 weeks for subjects with a
  • •solitary brain lesion amenable to stereotactic radiosurgery) must have elapsed between the end of radiotherapy and study enrollment.
  • •8. Uncontrolled hypertension (diastolic > 100 mmHg or systolic > 140 mmHg). It is permissible for the subject to receive treatment with antihypertensive medication to maintain blood pressure within required parameters.
  • •9. Clinically significant electrocardiogram (ECG) changes that obscure the ability to assess the RR, PR, QT, QTc, and QRS intervals.
  • •10. Ascites or pleural effusion requiring chronic medical intervention.
  • •11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
  • •12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment or treatment with small molecule tyrosine kinase inhibitors (TKIs) within 2 weeks before study drug treatment. Prior and concurrent use of hormone replacement therapy is permitted.
  • •13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug reatment. Radiation treatment to all sites of measureable disease unless progression is
  • •documented after radiation. No target lesion should be selected within the reviously irradiated field unless there was progression at that lesion following radiation.
  • •14. Participated in clinical drug trials within 4 weeks (2 weeks for small molecule TKIs) before study drug treatment. Current participation in other investigational procedures.
  • •15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
  • •16. History of hypersensitivity to any of the study drugs or to any excipients.
  • •17. Concurrent use of CYP3A4 inducers or inhibitors.
  • •18. Any known pre-existing condition including substance abuse that could interfere with subject’s participation in and completion of the protocol.

研究者

发起方
DAIICHI SANKYO DEVELOPMENT LTD.

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