NCT00719836已完成1 期
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
S*BIO6 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2008年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 6
- 主要终点
- Phase 1: To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced myeloid malignancies
研究概览
简要总结
This study consists of two phases: the first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with advanced myeloid malignancies; the second portion of the study is a Phase 2 study to define the efficacy and safety profile of single-agent SB1518 at the recommended dose in subjects with chronic idiopathic myelofibrosis (CIMF).
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
- •During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:
- •Subjects with Acute Myelogenous Leukemia (AML)
- •Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase
- •Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis
- •Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
- •Subjects with Advanced Myelofibrosis (MF)
- •In Phase 2, subjects with CIMF (as well as post ET/PV MF)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
- •Able to understand and willing to sign the informed consent form
排除标准
- •Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase;
- •Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study;
- •Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
- •Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
- •Known active hepatitis A, B, or C;
- •Women who are pregnant or lactating.
结局指标
主要结局
Phase 1: To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced myeloid malignancies
时间窗: Throughout the study
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose.
时间窗: Throughout the study
次要结局
- Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies(Throughout the study)
- Assess the pharmacokinetic and pharmacodynamic profile of SB1518(Throughout the study)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
1 期
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic MyelofibrosisMyeloproliferative DisordersEssential ThrombocythemiaPolycythemia VeraMyelofibrosisNCT00745550S*BIO55
进行中（未招募）
1 期
Study of 225Ac-ABD147 to Establish Optimal Dose in Patients With SCLC and LCNEC of the Lung That Previously Received Platinum-based ChemotherapySmall-Cell Lung Cancer (SCLC)Large Cell Neuroendocrine Carcinoma of the LungNCT06736418Abdera Therapeutics Inc.17
已完成
1 期
Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside TamoxifenBreast CancerNCT02285179The Netherlands Cancer Institute189
招募中
1 期
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple MyelomaNCT04973605BeOne Medicines246
进行中（未招募）
1 期
A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic AdenocarcinomaMetastatic Pancreatic AdenocarcinomaNCT05249101CG Pharmaceuticals, Inc70