EUCTR2005-004323-18-DK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 160 人开始时间: 2006年1月18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
- 160
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 clinical benefit from AMG 706 in the judgment of the investigator
- •Subject has received AMG 706 treatment for at least 8 weeks or until the first protocol-specified tumor evaluation, whichever is longer
- •Subject has been treated with AMG 706 in the previous study within the last 14 days (if > 14 days since date of last AMG 706 treatment, the subject will require repeat hematology and chemistry laboratory testing to confirm meet the laboratory criteria)
- •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
- •Current uncontrolled hypertension, defined as systolic BP > 145 mm Hg or diastolic BP > 90 mm Hg
- •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 date of AMG 706 treatment on a previous study has been > 14 days: • absolute neutrophil count (ANC) < 1.5 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 limits of normal (ULN), or AST > 5.0 x ULN if secondary to liver metastasis • total bilirubin > 2 x ULN 4.2.3
- •Medications
- •Coumarin-type anticoagulants (including warfarin) > 2 mg/day must not be administered within 7 days before study day 1
- •Currently or previously treated with rifampin or phenobarbital (within 14 days of study day 1) or ketoconazole, itraconazole, erythromycin, clarithromycin, nefazodone, cyclosporine, tacrolimus, and any HIV protease inhibitor (within 7 days of study day 1)
- •Concurrent therapy with St. John’s Wort.
- •Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breastfeeding
- •Subject is not using adequate contraceptive precautions
- •Subject has known sensitivity to any of the products to be administered during dosing
- •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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