CTRI/2010/091/001245已完成3 期
A Phase 3, Randomized, Double-Blinded Study of IMC-1121B andBest Supportive Care (BSC) Versus Placebo and BSC in the Treatmentof Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaFollowing Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ImClone LLC
- 入组人数
- 348
- 试验地点
- 12
- 主要终点
- Evaluate the overall survival (OS) of patients with metastatic gastric cancer (including adenocarcinomas of the gastroesophageal junction [GEJ]) following disease progression on first-line platinum- or fluoropyrimidine-containing combination chemotherapy who undergo treatment with the MAb IMC-1121B plus BSC versus placebo plus BSC.
研究概览
简要总结
Placebo-controlled, multicenter Phase 3 study of 615 patients with metastatic gastric cancer (including adenocarcinomas of the gastroesophageal junction) and disease progression on standard first-line chemotherapeutic regimens. Patients will be randomized on a 2:1 basis to receive BSC plus IMC-1121B administered every 2 weeks or BSC plus placebo administered every 2 weeks, respectively. Patients will undergo radiographic assessment of disease status every 6 weeks. Patients will be treated until there is evidence of progressive disease (PD), toxicity requiring cessation, withdrawal of consent, or until other withdrawal criteria are met. For India: 14 sites and estimated to randomize 30 pts. Tentative randomization start in India: 15 September 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Each patient must meet the following criteria to be enrolled in this study.
- •The patient has histologically- or cytologically-confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma (patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ).
- •The patient has metastatic disease or locally recurrent, unresectable disease.
- •â€¢ Patients with nonregional lymph node metastases are eligible; lymph node metastases must be measurable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0 • Patients with locally-recurrent, unresectable disease are eligible.
- •â€¢ For patients who have received prior radiation therapy, measurable or evaluable lesions must be outside the radiation field, or (for lesions within the radiation field) there must be documented progression following radiation therapy.
- •The patient has measurable disease and/or evaluable disease.
- •Measurable disease is defined as at least one unidimensionally-measurable target lesion (≥ 20 mm with conventional techniques or ≥ 10 mm by spiral CT), as defined by RECIST Version 1.
- •Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST.
- •The patient has experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy.
- •â€¢ Acceptable first-line regimens for this study are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-FU, capecitabine, or S-1).
- •â€¢ Elevations in carcinoembryonic antigen or other tumor markers without radiographic evidence of progression do not constitute satisfactory evidence of progression on first-line therapy.
- •â€¢ Patients who are intolerant to first-line chemotherapy regimens are eligible provided there is disease progression within 4 months after the last dose of firstline therapy.
- •â€¢ Patients who have had one or more component(s) of first-line chemotherapy discontinued because of toxicity, but continued to receive the other component(s) of first-line therapy (eg, a FOLFOX regimen in which the oxaliplatin was stopped and the 5-FU/leucovorin was continued), are eligible following disease progression.
- •â€¢ Prior adjuvant therapy is permitted, and patients with disease progression during adjuvant chemotherapy are eligible, provided that disease progression occurs within 6 months after the completion of adjuvant therapy.
- •Patients who experience disease progression more than 6 months after the last dose of adjuvant therapy should receive first-line therapy for metastatic disease, with subsequent progression on first-line therapy a requirement for eligibility.
- •The patient’s disease is not amenable to potentially curative resection.
- •The patient is ≥ 18 years of age.
- •The patient has a life expectancy of ≥ 12 weeks.
- •The patient has resolution to Grade ≤ 1 (or to Grade ≤ 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.02, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
- •The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-
- •The patient has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) [or 5.0 x the ULN in the setting of liver metastases].
- •The patient’s urinary protein is ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study).
- •The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/μL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/μL.
- •The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).
- •Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin.
- •If receiving warfarin, the patient must have an INR ≤ 3.0 and no active bleeding (ie, no bleeding within 14 days prior to first dose of study therapy) or pathological condition present that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
- •Patients on anticoagulation therapy with unresected primary tumors or local tumor recurrence following resection are not eligible.
- •If the patient has received prior anthracycline therapy as part of his or her first-line regimen, the patient is able to engage in ordinary physical activity without significant fatigue or dyspnea (equivalent to New York Heart Association Class I function).[57]
- •Because the teratogenicity of IMC-1121B is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods).
- •Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
- •The patient is able to provide informed written consent and is amenable to compliance with protocol schedules and testing.
排除标准
- •Patients who meet any of the following criteria will be excluded from the study.
- •The patient has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization.
- •The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization.
- •The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
- •The patient has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.
- •The patient has uncontrolled or poorly-controlled hypertension despite standard medical management.
- •The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization.
- •The patient has received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization.
- •The patient has received any investigational therapy within 30 days prior to randomization.
- •The patient has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization.
- •The patient has received prior therapy with an agent that directly inhibits VEGF or VEGFR-2 activity (including bevacizumab), or any antiangiogenic agent.
- •The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents.
- •Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
- •The patient has a known allergy to any of the treatment components.
- •The patient is pregnant or lactating.
- •The patient is known to be positive for infection with the human immunodeficiency virus.
- •The patient has known alcohol or drug dependency.
- •The patient has a concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm.
- •A patient with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years.
结局指标
主要结局
Evaluate the overall survival (OS) of patients with metastatic gastric cancer (including adenocarcinomas of the gastroesophageal junction [GEJ]) following disease progression on first-line platinum- or fluoropyrimidine-containing combination chemotherapy who undergo treatment with the MAb IMC-1121B plus BSC versus placebo plus BSC.
时间窗: The time point of disease progression is evaluated at the point in time when clinically recorded and overall survival at the time of death.
次要结局
- To evaluate the progression-free survival (PFS), including 12-week PFS rate, associated with IMC-1121B versus placebo? To evaluate the objective response rate (ORR)? To evaluate the duration of response? To evaluate the quality of life (QoL)? To evaluate the safety profile of IMC-1121B? To examine the pharmacodynamic profile of IMC-1121B? To assess the immunogenicity of IMC-1121B
研究者
研究点 (12)
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