NCT02501603已完成2 期
An Open-label, Multicenter Phase II Study of Afatinib Plus Weekly Taxol as Second Line Treatment for Advanced/Recurrent Gastric and Gastroesophageal Junction Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- compare progression free survival as measured by RECIST 1.1
研究概览
简要总结
For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for target enriched patients in gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
- •EGFR 2+ or 3+ expression (immunohistochemistry)
- •ECOG performance status of 0 to 1
- •Male or female; ≥ 19 years of age
- •Documented disease progression after one prior therapy, in locally advanced or metastatic setting
- •patients received last adjuvant chemotherapy less than six months can be enrolled into this study
- •Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
- •Subjects with measurable lesion (using RECIST 1.1 criteria)
- •Subjects who meet the following criteria:
- •Absolute neutrophil count (ANC) ≥ 1000 /µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
- •Platelet count ≥ 80,000/ µL
- •Serum creatinine < 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥50 mL/min using Cockcroft, Gault method
- •AST (SGOT) and ALT (SGPT) : 3 x upper limit of normal (ULN) (If there is Liver Metastasis : 5 x upper limit of normal (ULN))
- •Total bilirubin : 1.5 x upper limit of normal (ULN)
- •Provision of written informed consent prior to any study procedure
排除标准
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
- •Any previous chemotherapy or immunotherapy within 2 weeks
- •Any major operation or irradiation within 4 weeks of baseline disease assessment
- •Two or more previous systemic cytotoxic chemotherapy (adjuvant chemotherapy is not counted)
- •Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
- •Previously taxol(paclitaxel)-exposed patients
- •Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- •Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
- •Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
- •Pregnant or lactating female
- •Patients with contraindicated medication
- •History of interstitial lung disease (ILD) or presence of ILD on chest X-ray
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
研究组 & 干预措施
afatinib plus paclitaxel
Experimental
afatinib plus paclitaxel
干预措施: afatinib (Drug)
afatinib plus paclitaxel
Experimental
afatinib plus paclitaxel
干预措施: paclitaxel (Drug)
结局指标
主要结局
compare progression free survival as measured by RECIST 1.1
时间窗: Every 6 weeks until progression, an expected average of 10 months
To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker
次要结局
- safety as measured by CTCAE(every 3 weeks until progression, an expected average of 10 months)
- antitumor efficacy as measured by RECIST 1.1(every 6 weeks until progression, an expected average of 10 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/CisplatinSmall Cell Lung CancerNCT02875457Third Military Medical University100
Unknown
不适用
Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric CancerAdvanced Gastric CancerNCT03255811DongMa40
Unknown
2 期
MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric CancerGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaNCT02007148International Group of Endovascular Oncology51
终止
2 期
Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction CarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaNCT00256321University of California, Irvine4
已完成
1 期
Dovitinib Plus Docetaxel in Gastric CancerGastric CancerNCT01921673Asan Medical Center14