EUCTR2012-003798-25-DK进行中（未招募）1 期
Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
Merrimack Pharmaceuticals Inc.0 个研究点目标入组 151 人开始时间: 2013年7月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 151
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
- •Inclusion Criteria: To be eligible for this study, patients must meet all of the following criteria:
- •Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
- •Patients must have documentation of histologically or cytologically confirmed HER2 expression determined at any point during the course of disease as follows:
- •oHER2 3+ by IHC OR
- •oHER2 2+ by IHC and HER2 gene amplified by FISH or CISH
- •Patients must have progressed in one of the following settings: oWithin 6 months of a 5FU/platinum-based neoadjuvant or adjuvant therapy OR
- •oFollowing prior systemic therapy for metastatic or locally advanced disease which must include a standard front-line therapy combination of at least fluoropyrimidine/platinum given with or without trastuzumab
- •Patients must not have received any additional systemic therapy following progression after front-line therapy in the metastatic or locally advanced setting
- •Patients must be = 18 years of age
- •oFor patients enrolled in Taiwan, age must be = 20
- •Patients or their legal representatives must be able to understand and sign an informed consent
- •Patients should have evaluable or measurable disease =1 cm per
- •RECIST 1.1
- •Patients must have ECOG PS of 0, 1, or 2
- •Patients must have adequate hematologic status as evidenced by: oAbsolute neutrophil count (ANC) =1.5 x 109/L (unsupported by growth factors)
- •oPlatelet count =100 x 109/L
- •oHemoglobin =9 g/dL
- •Patients must have adequate hepatic function as evidenced by: oSerum total bilirubin =1.5 × the upper limit of normal (ULN) oAspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase =2.5 x ULN (5 × ULN is acceptable if liver metastases are present)
- •Patients must have adequate renal function as evidenced by: oSerum creatinine =1.5 × ULN or calculated clearance =60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Patients must have recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy to NCI CTCAE v.4.0 grade 1, baseline or less, except for alopecia
- •Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 6 months following the last dose of assigned study drug(s), in accordance with the
- •label recommendations for trastuzumab
- •Patients must have an unstained, archived formalin-fixed, paraffin- embedded (FFPE) tumor tissue sample available for submission to the Sponsor (or representative)
- •Patients must be willing and able to undergo a pre-treatment biopsy and have an identified lesion amenable to biopsy
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients cannot meet any of the follwing criteria to be eligible for the study:
- •Patients who previously received paclitaxel or other taxane treatment within (=) the last 6 months
- •Patients who are pregnant or lactating
- •Patients with an active infection or with an unexplained fever
- •>38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled)
- •Patients with known brain metastasis
- •Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies
- •Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL, unless a patient has been de- sensitized in accordance with institutional guidelines
- •Patients with a known history of hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any other components oPatients who previously had a mild infusion reaction to trastuzumab and were later re-treated with no additional infusion reactions are allowed on study.
- •Patients who have received other recent anti-tumor therapy. This includes the following:
- •o Investigational therapy administered within (=) 28 days prior to the first scheduled day of dosing MM-111
- •o Dosing within (=) 28 days since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed
- •o Any standard chemotherapy or radiation or other therapy within (=)
- •14 days prior to the first scheduled dose of MM-111
- •o Patients already receiving trastuzumab do not require a wash-out period from trastuzumab, nor a trastuzumab loading dose if trastuzumab has been received within the last 4 weeks
- •o Patients receiving or have received palliative radiation are allowed on study
- •Patients with active or prior history of New York Heart Association (NYHA) congestive heart failure or left ventricular ejection fraction (LVEF) <50%
- •History of myocardial infarction within (=) 12 months of enrollment
- •Uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg)
- •Known angina pectoris requiring medication
- •o Patients with stable angina with no symptoms for > 2 years are allowed on study
- •Known clinically significant heart valve disease
- •Known history of high-risk arrhythmias requiring medical attention
- •(chronic stable well controlled atrial fibrillation is permissible)
- •Active gastrointestinal bleeding, if deemed clinically significant by the
- •Investigator
- •Patients who have received prior maximum cumulative anthracycline
- •o Doxorubicin or liposomal doxorubicin doses >360 mg/m2
- •o Mitoxantrone >120 mg/m2 and idarubicin >90 mg/m2 oDEpirubicin doses higher than 720 mg/m2
- •o Other (e.g., liposomal doxorubicin or other anthracycline equivalent of 360 mg/m2 of doxorubicin)
- •oIf more than 1 anthracycline has been used, the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin
- •Patients with known human immunodeficiency virus (HIV). Patients with Hepatitis B surface antigen (carriers) may be enrolled but must receive nucleoside/nucleotide analogue or other suitable treatment for Hepatitis B per institutional guidelines
- •Patients with any other medical or psychological condition, deemed by the investigator as likely to interfere with a patient's ability to sign informed consent or cooperate and participa
研究者
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