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临床试验/EUCTR2011-002893-21-DE
EUCTR2011-002893-21-DE进行中（未招募）1 期

A PHASE II, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF CARBOPLATIN/PACLITAXEL AND CARBOPLATIN/PACLITAXEL/BEVACIZUMAB WITH AND WITHOUT GDC-0941 IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR RECURRENT NON-SMALL CELL LUNG CANCER

Genentech, Inc.0 个研究点目标入组 496 人开始时间: 2012年2月21日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
496
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

  • •For ALL Arms, patients must meet the following criteria to undergo screening procedures:
  • •Signed Informed Consent Form
  • •All patients must consent to the collection of an archival formalin-fixed paraffin embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue (10–15 preferred, minimum of 5 slides required) or a newly collected tumor sample for PIK3CA amplification testing and/or PTEN IHC, as well as for other protocol-mandated exploratory assessments.
  • •Availability of archival tissue for biomarker testing must be confirmed by the site prior to any study-specific screening procedures.
  • •Suitability of archival non-FFPE tissue must be evaluated by the central or local study pathologist and discussed with the Genentech Medical Monitor.
  • •Patients with no available archival tissue (or if the sample is difficult to obtain) may undergo a new tumor biopsy to meet eligibility criteria, as long as the patient consents to this and the biopsy can be obtained with minimal risk and discomfort to the patient as determined by the local investigator.
  • •Adequate tumor tissue content of the patient’s archival tumor sample must be confirmed by the site’s pathologist or a third-party vendor prior to randomization of the patient (please see Section 4.5.1.e for details).
  • •For Arms A and B, patients must meet the following criteria to be eligible:
  • •Histologically documented advanced (Stage IV) or recurrent squamous NSCLC
  • •Diagnoses of squamous NSCLC that are based on cytology alone are not acceptable.
  • •Mixed tumors should be categorized according to the predominant cell type.
  • •For Arms C, D, E & F,, patients must meet the following criteria to be eligible:
  • •Histologically documented advanced (Stage IV) or recurrent non-squamous NSCLC
  • •Diagnoses of non-squamous NSCLC that are based on cytology alone are not acceptable.
  • •Mixed tumors should be categorized according to the predominant cell type.
  • •For ALL Arms, patients must meet the following criteria to be eligible:
  • •Age = 18 years
  • •ECO performance status of 0 or 1 (see Appendix E)
  • •Disease that is measurable per RECIST v1.1 (see Appendix C)
  • •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
  • •Absolute neutrophil count (ANC) = 1500 cells/µL
  • •Without granulocyte colony stimulating factor support within 2 weeks prior to randomization
  • •Platelet count = 100,000/µL
  • •Without transfusion within 2 weeks prior to randomization
  • •Hemoglobin = 9.0 g/dL (90 g/L)
  • •Patients may be transfused to meet this criterion.
  • •Albumin = 3.0 g/dL (30 µmol/L)
  • •Total bilirubin = 1.5 x ULN
  • •AST and ALT = 3.0 x ULN
  • •Serum creatinine = 1.5 x ULN, or creatinine clearance = 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation:
  • •(140-age) x (weight in kg) x (0.85 if female) / 72 x (serum creatinine in mg/dL)
  • •INR = 1.5 and aPTT = 1.5 x ULN, except for patients receiving allowed anti-coagulation therapy
  • •For patients without known type II diabetes, the following is required
  • •Fasting blood glucose < 135 mg/dL (7.49 mmol/L) and HbA1c < 7.0%
  • •For patients with type II diabetes receiving oral anti-hyperglycemic therapy the following is required:
  • •Fasting blood glucose < 160 mg/dL (8.88 mmol/L) and HbA1c < 8.5
  • •Stable regimen of oral anti-hyperglycemic therapy without the use of insulin for at least 3 weeks prior to randomization
  • •Fasting blood glucose levels < 160 mg/dL (8.88 mmol/L) and no hypoglycemia during

排除标准

  • •Exlusion criteria for all arms:
  • •NSCLC with documented EGFR mutation associated with response to
  • •EGFR inhibitors or documented fusion gene involving the anaplastic
  • •lymphoma kinase (ALK) gene (such as EML4-ALK)
  • •Prior therapy (including chemotherapy, antibody therapy, tyrosine
  • •kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or
  • •investigational therapy) before Day1 of Cycle1 for the treatment of
  • •advanced (Stage IV) or recurrent NSCLC
  • •Patients who received prior adjuvant chemotherapy or radiotherapy for
  • •NSCLC are not excluded if the time interval from completion of adjuvant
  • •therapy until disease progression is >12 months
  • •Patients who received prior palliative radiotherapy for metastatic or
  • •lobar lesions (not including target lesions) are not excluded (if >2 weeks
  • •prior to Day1 of Cycle1)
  • •Patients who receive hormone-replacement therapy or oral
  • •contraceptives are not excluded
  • •Patients who received herbal therapy >2 weeks prior to Day1 of Cycle1
  • •are not excluded.
  • •Evidence of tumor invading major blood vessels on imaging
  • •The investigator or the local radiologist must exclude evidence of tumor
  • •that is fully contiguous with, surrounding, or extending into the lumen of
  • •a major blood vessel (eg pulmonary artery or superior vena cava)
  • •Known CNS disease except for treated brain metastases
  • •Treated brain metastases are defined as having no evidence of
  • •progression or hemorrhage >2 weeks after treatment & no ongoing
  • •requirement for dexamethasone, as ascertained by clinical examination
  • •and brain imaging (MRI or CT) during the screening period
  • •Stable doses of non-enzyme inducing anti-convulsants are allowed
  • •Treatment for brain metastases may include whole brain radiotherapy,
  • •radiosurgery (Gamma Knife, LINAC, or equivalent) or a combination as
  • •deemed appropriate by the treating physician and if >2 weeks have
  • •passed since radiation treatment
  • •Patients with CNS metastases treated by neurosurgical resection or
  • •brain biopsy performed within 3 months prior to Day1 of Cycle1 will be
  • •XML File Identifier: PrAw1g27Ar6SWeX5RemdPE6VaQM=
  • •Leptomeningeal disease
  • •Malignancies other than NSCLC successfully treated within 3 years prior
  • •to randomization, except for adequately treated carcinoma in situ of the
  • •cervix, basal or squamous cell skin cancer, localized prostate cancer
  • •treated surgically with curative intent, & carcinoma in situ of any
  • •anatomic location treated with curative intent
  • •Type I diabetes
  • •Type II diabetes requiring chronic therapy with insulin
  • •Requirement for supplemental oxygen therapy to perform activities of
  • •daily living
  • •Unstable angina
  • •Serious cardiac arrhythmia requiring medication during the study
  • •New York Heart Association Class II or greater congestive heart failure
  • •History of malabsorption syndrome or other condition that would
  • •interfere with enteral absorption
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研究者

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