EUCTR2005-004323-18-GB进行中（未招募）1 期
An Open Label Treatment Extension Study of AMG706
Amgen Inc.0 个研究点目标入组 64 人开始时间: 2005年10月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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
- 性别
- All
入选标准
- •Women and men > 18 years old, with solid tumors, previously treated with AMG 706 on an Amgen protocol
- •Subject has completed the planned duration of AMG 706 treatment on a separate Amgen protocol and has been evaluated as having stable disease or better (as defined in the previous protocol) or is no longer eligible to continue AMG 706 treatment on a separate Amgen protocol for reasons other than AMG 706 intolerance, but is receiving or has potential to receive clinical benefit from AMG 706 in the judgment of the investigator
- •Subject must meet one of the following criteria:
- •Subject has received AMG 706 treatment for at least 8 weeks or until the first protocol-specified tumor evaluation, whichever is longer or
- •Subject has received at least one dose of AMG 706 but did not receive AMG 706 for > 8 weeks or undergo a tumor evaluation due to the construct of the parent protocol. These subjects will be evaluated for eligibility on a case by case basis by the sponsor
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease Related
- •Discontinued from an AMG 706 study due to an adverse event considered by the investigator to be related to AMG 706 treatment, including intolerance to AMG 706, or for any other reason that a subject’s safety could be compromised with continued AMG 706 treatment
- •Has been off AMG 706 treatment for > 42 days before study day 1
- •Participating in any intervening investigational device or drug study(s) between the previous AMG 706 study and this AMG 706 study, or is receiving any investigational agent(s) other than AMG 706
- •Uncontrolled hypertension (resting blood pressure > 150/ 90 mm Hg). Anti- hypertensive medications are allowed if the subject is stable on their current dose at time of study day 1.
- •Requires additional systemic anticancer therapy for the primary tumor
- •The following laboratory exclusion criteria are applicable for repeat hematology and chemistry laboratory testing for subjects whose last dose of AMG 706 treatment on the previous study has been > 14 days from the first dose of AMG 706 on this extension study:
- •absolute neutrophil count (ANC) < 1.0 x 109 /L
- •platelet count < 100 x 109 /L
- •hemoglobin < 9 g/dL
- •serum creatinine > 2.0 mg/dL (> 177 µmol/L) or calculated clearance < 40 mL/min
- •Aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) (if liver metastases are present = 5 x ULN)
- •Alanine aminotransferase (ALT) > 2.5 x ULN ( if liver metastases are present =5 x ULN)
- •Alkaline phosphatase > 2.0 x ULN ( if liver or bone metastases are present = 5 x ULN)
- •Total bilirubin > 2.0 x ULN (except for subjects with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader° UGT1A1 Molecular Assay prior to randomization. Subjects enrolled with Gilbert syndrome must have a total bilirubin < 3 x ULN)
- •Medications
- •Medications that are metabolized by CYP3A4, 2D6 and 2C9 and that have a narrow therapeutic window should be used with caution when given concomitantly with AMG 706, or alternative therapeutic agents with less drug interaction potential should be considered.
- •Subject of child-bearing potential is evidently pregnant (eg, positive beta-human chorionic gonadotropin test) or is breastfeeding
- •Is not using adequate contraceptive precautions
- •Subject has known sensitivity to any of the products to be administered during dosing Known hypertension to study medication (AMG706)
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- •Subject has any medical condition that, in the investigator’s opinion, makes the subject unsuitable for study participation
研究者
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