NCT00911898已完成1 期
A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
研究概览
简要总结
This study is an open-label Phase 1 trial of MM-111.
详细描述
Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients must have histologically or cytologically confirmed advanced cancer that is:
- •HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation
- •Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory
- •Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining
- •Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.
- •Patients must be >= 18 years of age
- •Patients or their legal representatives must be able to understand and sign an informed consent
- •Patients may have measurable or non-measurable tumor(s)
- •Patients should have ECOG Performance Score (PS) 0 or 1
- •Patients must have adequate bone marrow reserves as evidenced by:
- •Absolute neutrophil count (ANC) >= 1,500/uL and
- •Platelet count >= 100,000/uL
- •Hemoglobin >= 9 g/dL
- •Patients must have tumor tissue amenable to biopsy
- •Patients must be willing to undergo biopsy prior to treatment to MM-111
排除标准
- •Patients for whom potentially curative antineoplastic therapy is available
- •Patients who are pregnant or lactating
- •Patients with an active infection or with an unexplained fever greater than 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 untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
- •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 history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)
- •Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)
研究组 & 干预措施
MM-111
Experimental
干预措施: MM-111 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
时间窗: 28 days
The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.
次要结局
- To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity(December 2011)
- To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)(December 2011)
研究者
研究点 (4)
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