NCT00359086已完成2 期
A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Response rate
研究概览
简要总结
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Pathologic confirmation of relapsed or refractory lymphoma.
- •DLBCL stage II-IV
- •Follicular lymphoma
- •At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI).
- •Prior treatment:
- •DLBCL cohort: Disease progression following initial therapy and transplant (unless the patient is ineligible or refused transplant). There is no limit to number of prior therapies.
- •Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or refractory to standard therapy and/or existing therapies or are not eligible for or are unlikely to achieve clinical benefit from those therapies. Patients must have failed 3 or more prior therapies.
- •Must have at least one of the following considered related to disease:
- •Local symptoms due to progressive or bulky nodal disease.
- •Compromise of normal organ function due to progressive or bulky disease.
- •Presence of systemic B symptoms.
- •Presence of symptomatic extranodal disease.
- •Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia or thrombocytopenia, or hypersplenism.
- •ECOG performance status of 0 or
- •Aged 18 years or older.
- •Laboratory requirements.
排除标准
- •Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
- •Pregnant or lactating women.
- •Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever >38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.
- •Patients with a history of pericardial disease.
- •Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.
- •Patients with significant cardiac abnormalities.
- •Patients with serious illnesses, medical conditions, or other medical history which would be likely to interfere with patient's participation in the study or with the interpretation of the results.
- •Patients who have been treated with any investigational drug within 28 days prior to study initiation.
- •Known hypersensitivity to HDAC inhibitors and to any components of MGCD
- •Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
- •Central nervous system lymphoma and lymphoma involving leptomeningeal area.
研究组 & 干预措施
1
Experimental
干预措施: MGCD0103 (Drug)
结局指标
主要结局
Response rate
时间窗: 1 year (anticipated)
次要结局
- Progression-free survival(1 year (anticipated))
- Safety profile(1 year (anticipated))
- Duration of objective response(1 year (anticipated))
- Pharmacokinetics(1 year (anticipated))
- Pharmacodynamics(1 year (anticipated))
研究者
研究点 (5)
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