NCT00493571已完成1 期
Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes
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
- 16
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Gimatecan
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of gimatecan that can be given to treat myelodysplastic syndrome (MDS).
详细描述
The Study Drug:
Gimatecan is designed to block the function of an important protein (topoisomerase I) in cancer cells that helps repair damage to DNA (the genetic material of cells). When this protein is blocked, cancer cells may die.
Screening Tests:
Before you can start receiving the study drug, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.
- You will have a physical exam.
- Your complete medical history will be recorded.
- Your vital signs (blood pressure, pulse, breathing rate, and temperature), height, and weight will be measured.
- You will be asked how well you are able to perform the normal activities of daily living (a performance status evaluation).
- You will be asked about any medications you may be taking.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- Women who are able to have children must have a negative blood (about 2 teaspoons) or urine pregnancy test.
- You will have a bone marrow aspirate performed. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
- If your doctor thinks it is necessary, you will have a bone marrow biopsy when you have the bone marrow aspirate done. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
- You will complete a questionnaire to see how the disease may be affecting your ability to do your daily activities. The questionnaire will take about 15 minutes to complete.
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 with MDS with >/= 5% blasts or IPSS risk group intermediate (1 or 2) or high (i.e., IPSS score 0.5 or higher).
- •Patients must have failed prior therapy with either chemotherapy (e.g., ara-C-based chemotherapy, etc) or biologic agents (e.g., hypomethylating agents, arsenic, thalidomide, CC5013, farnesyl transferase inhibitors, ATG, cyclosporine, etc).
- •Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of Gimatecan in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have normal organ function as defined below: 1) Total bilirubin: </= 1.5 x institutional upper limit of normal; 2) ALT(SGPT): </= 2.5 x institutional upper limit of normal; 3) Creatinine: </= 1.5 x institutional upper limit of normal.
- •The effects of Gimatecan on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential (ie, not post-menopausal for at least 12 months and not surgically sterile) and men must agree to use double-barrier contraception prior to study entry, for the duration of study participation, and for 3 months following discontinuation of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have received only supportive care (transfusions and/or hematopoietic growth factors) for MDS.
- •Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives of the agent in question (6 weeks for nitrosoureas or mitomycin C), whichever is greater, prior to entering the study or those who have not recovered to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier. The use of hydroxyurea is allowed up to 48 hours prior to the start of therapy with Gimatecan.
- •Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia requiring and not responding to medical intervention, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Women who are pregnant or breast-feeding.
研究组 & 干预措施
Gimatecan
Experimental
Gimatecan Starting dose: 0.6 mg capsules administered orally once daily.
干预措施: Gimatecan (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Gimatecan
时间窗: Evaulate with each 28 Day Cycle
For purposes of estimating the MTD, 5 dose levels of Gimatecan initially considered. These dose levels are 3 mg, 5 mg, 7.5 mg, 8.75 mg, and 10 mg orally per cycle. Dose escalation based on toxicities observed through the first cycle.
次要结局
- Efficacy in terms of complete remission , complete remission w/ incomplete platelet or neutrophil recovery (CRp and CRn, respectively), partial remission , and hematologic improvement.(Up to 12 Months on Study)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal CancerOvarian Epithelial CancerFallopian Tube CancerPrimary Peritoneal CancerNCT04029909Lee's Pharmaceutical Limited12
已完成
1 期
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid TumorsSolid TumorsNCT00420485Novartis Pharmaceuticals120
进行中（未招募）
1 期
Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid MalignanciesAdvanced CancersMelanomaNCT02668770M.D. Anderson Cancer Center28
已完成
1 期
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung CarcinomaCarcinoma, BronchogenicNCT00102505Pharmacyclics LLC.36
终止
1 期
Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL AmyloidosisMyelomaNCT01807286M.D. Anderson Cancer Center3