EUCTR2011-003720-12-GB进行中（未招募）1 期
A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF MetMAb IN COMBINATION WITH PACLITAXEL + CISPLATIN OR CARBOPLATIN AS FIRST-LINE TREATMENT FOR PATIENTS WITH STAGE IIIB (T4 DISEASE) OR IV SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 109
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
入选标准
- •Written informed consent
- •Male or female, 18 years of age or older
- •ECOG performance status of 0 or 1
- •Stage IIIB or IV NSCLC tumors of squamous histology (Stage IIIB NSCLC eligible only if not amenable to definitive surgery or radiation therapy) Patients with stable, treated brain metastases are eligible as long as there is no evidence of progression after treatment and no ongoing requirement for dexamethasone or other corticosteroid treatment.
- •Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
- •Adequate hematologic, hepatic, and renal function
- •Adequate contraception, during the treatment period and for at least 90 days after the last dose of study drug/placebo or 6 months after the last dose of paclitaxel
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Prior systemic treatment for Stage IIIB or IV squamous NSCLC
- •NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
- •Prior exposure to experimental treatment targeting either the HGF or Met pathway
- •Tumors confirmed to have EGFR activating mutations who are suitable for anti-EGFR therapy
- •Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1
- •History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years (except for in situ cancer or basal or squamous cell skin cancer)
- •Serum calcium > ULN corrected for low serum albumin concentrations
- •Uncontrolled diabetes (fasting serum glucose level > 200 mg/dL)
- •Pregnancy or lactation
- •Significant history of cardiovascular disease
- •Serious active infection or other serious underlying medical conditions
- •Known HIV positivity
- •Any major surgery, major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1, or an anticipated need for major surgery during the study
- •Known sensitivity to any component of cisplatin, carboplatin, or paclitaxel
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy and the safety of MetMAb in combination with either bevacizumab + platinum + paclitaxel or pemetrexed + platinum in lung cancer patients (non-squamous non-small cell lung cancer).MET DIAGNOSTIC-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)MedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10025048 Term: Lung cancer non-small cell recurrent System Organ Class: 100000004864EUCTR2011-003719-42-GBGenentech, Inc259
进行中（未招募）
不适用
A clinical trial to evaluate the activity of a new targeted drug, onartuzumab, in patients with metastatic triple negative breast cancerMetastatic, triple-negative breast cancerMedDRA version: 17.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-020101-32-BEGENENTECH, Inc.186
进行中（未招募）
1 期
A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF METMAB IN COMBINATION WITHPACLITAXEL AND BEVACIZUMAB IN PATIENTS WITH METASTATIC, TRIPLE-NEGATIVE BREAST CANCEREstudio aleatorizado, en fase II, multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de metmab en combinación con paclitaxel y bevacizumab en pacientes con cáncer de mama metastásico triple negativoMetastatic, triple-negative breast cancerCáncer de mama metastásico triple negativoMedDRA version: 12.1Level: PTClassification code 10055113Term: Breast cancer metastaticEUCTR2010-020101-32-ESGENENTECH, Inc.120
进行中（未招募）
不适用
A study to evaluate the efficacy and the safety of MetMAb in combination with paclitaxel+cisplatin or paclitaxel+carboplatin in patients with either locally advanced or metastatic squamous cell lung cancer.MET DIAGNOSTIC-POSITIVE NON-SMALL CELL LUNG CANCER(NSCLC)MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 100000004864EUCTR2011-003720-12-DEF. Hoffmann-La Roche Ltd.110
进行中（未招募）
不适用
A study to evaluate the efficacy and the safety of MetMAb in combination with paclitaxel+cisplatin or paclitaxel+carboplatin in patients with either locally advanced or metastatic squamous cell lung cancerMET DIAGNOSTIC-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-003720-12-ITF. HOFFMANN - LA ROCHE LTD.110