NCT02303262已完成2 期
A Phase II Study of Mocetinostat Administered With Gemcitabine for Patients With Metastatic Leiomyosarcoma With Progression or Relapse Following Prior Treatment With Gemcitabine-Containing Therapy
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
- 20
- 试验地点
- 5
- 主要终点
- Response Rate (Per RECIST 1.1)
研究概览
简要总结
This is an open-label, multi-center, Phase II trial studying the combination of mocetinostat and gemcitabine in patients who have previously demonstrated disease progression either while, or within six months after, receiving chemotherapy with a gemcitabine-based regimen.
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
- •Age ≥ 18 years
- •Histologically documented leiomyosarcoma
- •Prior systemic therapy with a gemcitabine containing regimen
- •ECOG Performance Status of ≤ 1
- •Measurable metastatic disease with a target lesion that has increased in size by 20% in maximal dimension either during or within six months after treatment with chemotherapy using a gemcitabine containing regimen
- •Adequate organ function within 14 days of study entry
- •Patients or their legal representative must be able to read (or have read to them), understand, and sign a written informed consent (approved by the institutional review board) within 14 days prior to start of treatment.
排除标准
- •Concurrent, clinically significant, active malignancies (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN] in situ or melanoma in situ) (Stage II portion only)
- •Patients with baseline QTcF ≥ 480 msec
- •Patients with uncontrolled concurrent illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever > 38.5°C on the day of scheduled dosing
- •Patients with serious illnesses, medical conditions, or other medical history, including a prior history of pericarditis/pericardial effusion, or abnormal laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
- •Patients who have received any investigational drug within 28 days prior to Day 1 of study entry (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy
- •Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 72 hours prior to starting study drug or a urine pregnancy test shall be done on Day 1 of Cycle 1
- •Women of child bearing potential and their partners must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
- •Known hypersensitivity to HDAC inhibitors or to any of the components of mocetinostat
- •Known hypersensitivity to gemcitabine
- •Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take mocetinostat with water and recommendation to avoid agents that increase gastric pH
- •Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
研究组 & 干预措施
Mocetinostat and gemcitabine
Experimental
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
干预措施: Mocetinostat (Drug)
Mocetinostat and gemcitabine
Experimental
For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Response Rate (Per RECIST 1.1)
时间窗: 27 months
Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions.
次要结局
- Duration of Response(27 months)
- Progression Free Survival (PFS)(27 months)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
1 期
Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin LymphomaHodgkin LymphomaNCT02429375Memorial Sloan Kettering Cancer Center7
进行中（未招募）
1 期
Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent RhabdomyosarcomaRhabdomyosarcomaNCT04299113Jonsson Comprehensive Cancer Center14
进行中（未招募）
1 期
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial CancersFIGO Grade 1 Endometrial Endometrioid AdenocarcinomaFIGO Grade 2 Endometrial Endometrioid AdenocarcinomaMetastatic Endometrial Endometrioid AdenocarcinomaRecurrent Endometrial Endometrioid AdenocarcinomaNCT05538897National Cancer Institute (NCI)96
已完成
2 期
Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific GenesUrothelial CarcinomaNCT02236195Mirati Therapeutics Inc.17
进行中（未招募）
2 期
Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell CarcinomaRenal Cell CarcinomaNCT03552380Roberto Pili18