NCT00777309已完成2 期
A Randomized Phase 2 Study of Erlotinib Plus ARQ 197 Versus Erlotinib Plus Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)2 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
研究概览
简要总结
This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.
详细描述
This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC. The study will evaluate progression-free survival between the two arms.
A total of 154 patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent prior to study-specific screening procedures
- •≥ 18 years old
- •Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
- •≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
- •Females of childbearing potential must have a negative serum pregnancy test
- •Good organ function
- •Confirmed availability of archival pathology samples (10 unstained paraffin-embedded slides) or tissue block suitable for subsequent analysis of KRAS, EGFR, and c-Met
排除标准
- •Previous receipt of erlotinib or other EGFR inhibiting therapy
- •Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
- •Documented major surgical procedure within 4 weeks prior to randomization.
- •Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or other symptom-relieving medications
- •Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
- •Significant gastrointestinal disorder that, in opinion of Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn's disease, small or large bowel resection, malabsorbtion syndrome)
- •Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
- •Any known contraindication to treatment with ARQ 197 or erlotinib
- •Any known hypersensitivity to any of component of ARQ 197 or erlotinib
- •Other malignancy within 5 years of randomization, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value < 0.2 ng/ml or basal or squamous cell carcinoma of the skin
- •Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
- •Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
- •Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
研究组 & 干预措施
1
Experimental
Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily.
干预措施: ARQ 197 (Drug)
1
Experimental
Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily.
干预措施: Erlotinib (Drug)
2
Active Comparator
Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily
干预措施: Erlotinib (Drug)
2
Active Comparator
Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
次要结局
- Overall response rate (ORR)
- Evaluate overall survival (OS)
- Safety of ARQ 197 in combination with erlotinib in patients with NSCLC
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Randomized, Double-Blind Trial of Erlotinib/Pazopanib or Erlotinib/Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung CancerNon Small Cell Lung CancerNCT01027598SCRI Development Innovations, LLC202
已完成
2 期
Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by SurgeryRecurrent Renal Cell CarcinomaStage III Renal Cell CancerStage IV Renal Cell CancerType 1 Papillary Renal Cell CarcinomaType 2 Papillary Renal Cell CarcinomaNCT01688973National Cancer Institute (NCI)55
已完成
2 期
A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib AloneCarcinoma, Non-Small-Cell LungNCT00265317Pfizer162
已完成
2 期
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and NeckMetastatic Squamous Cell Carcinoma of the HypopharynxMetastatic Squamous Cell Carcinoma of the LarynxMetastatic Squamous Cell Carcinoma of the Oral CavityMetastatic Squamous Cell Carcinoma of the OropharynxRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7NCT01064479M.D. Anderson Cancer Center123
已完成
2 期
Erlotinib Hydrochloride in Treating Patients With Stage I-III Colorectal Cancer or AdenomaAdenomatous PolypRecurrent Colon CancerRecurrent Rectal CancerStage I Colon CancerStage I Rectal CancerStage IIA Colon CancerStage IIA Rectal CancerStage IIB Colon CancerStage IIB Rectal CancerStage IIC Colon CancerStage IIC Rectal CancerStage IIIA Colon CancerStage IIIA Rectal CancerStage IIIB Colon CancerStage IIIB Rectal CancerStage IIIC Colon CancerStage IIIC Rectal CancerNCT00754494National Cancer Institute (NCI)45