NCT00346385已完成1 期
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 9
- 主要终点
- Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of BB-10901
- Determine the maximum tolerated dose of this drug in these patients.
Secondary
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS During Dose Escalation:
- •Histologically or cytologically confirmed diagnosis of 1 of the following:
- •Small cell lung cancer (SCLC)
- •Other pulmonary tumors of neuroendocrine origin, including neuroendocrine carcinoma or non-SCLC with neuroendocrine features
- •Non-pulmonary small cell carcinoma
- •Metastatic carcinoid tumor
- •Other CD56-positive solid tumor
- •Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry
- •Relapsed or refractory disease
- •Must have received at least 1 but no more than 3 prior chemotherapy regimens* and recovered from any acute toxicities
- •No prior chemotherapy for carcinoid or neuroendocrine tumors
- •DISEASE CHARACTERISTICS During MTD Expansion:
- •Relapsed or refractory Small cell lung cancer (SCLC)
- •Metastatic Merkel Cell carcinomas
- •Ovarian carcinomas
- •At the MTD:
- •SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian patients must have received at least one platinum-based regimen.
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile blood pressure)
- •No active brain metastases; no evidence of active disease and no requirement for anticonvulsant medications or steroids.
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 3 months
- •ECOG performance status 0-2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Bilirubin ≤ 3 times ULN
- •No rapidly rising liver function tests (LFTs)
- •Pancreatic function, amylase and lipase within upper limit of normal.
- •No significant residual neurological or cardiac toxicity ≥ grade 2 after prior chemotherapy
- •No myocardial infarction within the past 6 months
- •No unstable angina pectoris
- •No uncontrolled congestive heart failure
- •No uncontrolled arrhythmia
- •No severe aortic stenosis
- •No history of multiple sclerosis or other demyelinating disease
- •No Eaton-Lambert syndrome (para-neoplastic syndrome)
- •No history of hemorrhagic stroke
- •No CNS injury with residual neurologic deficit
- •No ischemic stroke within the past 6 months
- •No history of pancreatitis
- •No current active infection or history of recurrent infection with varicella-zoster virus (shingles) or cytomegalovirus
- •No other concurrent serious infection
- •No chronic alcoholism
- •No other concurrent illness or condition that would interfere with study outcome
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments
时间窗: these tests will be conducted at various timepoints during a patients participation in the trial
次要结局
- Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level(PK is assessed during the first cycle (21 days) of a patients participation)
- Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM)(efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle)
研究者
研究点 (9)
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