EUCTR2012-003798-25-ES进行中（未招募）不适用
Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with orwithout Trastuzumab in Patients with ?Traditional? and ?Non-Traditional? HER2 ExpressingCarcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who HaveFailed Front Line Metastatic or Locally Advanced Therapy.
Merrimack Pharmaceuticals Inc.0 个研究点目标入组 180 人开始时间: 2013年4月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •Patients will be qualified for study participation based on the following inclusion 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 as follows:
- •o Traditional HER2 Group 1: Patients who are HER2 3+ by IHC OR HER 2 2+ by IHC and HER2 gene amplified by FISH or CISH
- •o Non-Traditional HER2 Group 2: Patients who are HER2 2+ by IHC and HER2 gene nonamplified by FISH or CISH
- •- For Traditional HER2 Group 1
- •o Patients must have received one prior systemic therapy for metastatic disease, which must be a standard fluoropyrimidine/platinum-based frontline therapy given with or without trastuzumab
- •- Non-Traditional HER2 Group 2
- •o Patients must have received one prior systemic therapy for metastatic disease which must be a standard fluoropyrimidine/platinum-based frontline therapy given without trastuzumab
- •- Patients must be ?18 years of age
- •- 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:
- •o Absolute neutrophil count (ANC) ?1500 cells/mm3
- •o Platelet count ?100,000 platelets/mm3
- •o Hemoglobin ?9 g/dL
- •- Patients must have adequate hepatic function as evidenced by:
- •o Serum total bilirubin ?1.5 × the upper limit of normal (ULN)
- •o Aspartate 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:
- •o Serum creatinine ?1.5 × ULN or calculated clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •- Patients must be recovered from the effects of any prior surgery, radiotherapy or other
- •antineoplastic therapy. NCI CTCAE v.4.0 up to grade 1 is acceptable for patients with preexisting peripheral neuropathy
- •- 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 60 days following the last dose of assigned study drug(s)
- •- Patients must have an archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue
- •- Patients must be willing and able to undergo a pre-treatment biopsy (this applies to the first
- •30 patients in each treatment group i.e. 30 for Traditional HER2 and 30 for Non-Traditional
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients will be disqualified from study participation based on the following exclusion criteria:
- •- Patients for whom potentially curative antineoplastic therapy is available
- •- Patients who previously received paclitaxel or other taxane treatment in the frontline or locally advanced setting
- •- 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
- •- Patients with a known history of hypersensitivity to trastuzumab or any of its components
- •(for group 1 only)
- •- Patients who have received other recent anti-tumor therapy. This includes the following:
- •o Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111
- •- 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
- •- Patients in the Traditional HER2 group already receiving trastuzumab do not require a wash-out period from trastuzumab (for group 1 only)
- •o Any standard chemotherapy or radiation or other therapy within 14 days prior to the
- •first scheduled dose of MM-111
- •o Patients who have not recovered from clinically significant effects of any prior surgery, radiotherapy or any other antineoplastic therapies. Patients with a known peripheral neuropathy must present with a grade 1 severity or less according to NCI CTCAE 4.0
- •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
- •- 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
- •- Patients who have received prior maximum cumulative anthracycline doses:
- •o Doxorubicin or liposomal doxorubicin doses >360 mg/m2
- •o Mitoxantrone >120 mg/m2 and idarubicin >90 mg/m2
- •o Epirubicin doses higher than 720 mg/m2
- •o Other (e.g., liposomal doxorubicin or other anthracycline equivalent of 360 mg/m2 of doxorubicin)
- •o If 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 to
- •likely interfere with a patient's ability to sign informed consent or cooperate and participate
- •in the study, or interfere with the interpretatio
研究者
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