NCT00741871已完成1 期
A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
S*BIO2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年7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
- 35
- 试验地点
- 2
- 主要终点
- To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.
研究概览
简要总结
This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.
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
- •Subjects with histologically documented diagnosis of a lymphoid malignancy as defined in the World Health Organization (WHO) classification scheme except for those listed in
排除标准
- •Subject must have received at least 2 prior regimens for their lymphoid malignancy, one of which was an anthracycline-containing combination regimen and have shown disease relapse or did not respond to the prior regimen
- •Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant
- •Subjects must have measurable lesions (at least one target lesion measuring 2cm in diameter) by computerized tomography (CT) scan
- •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
- •Exclusion Criteria:
- •Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma
- •History of or active Central Nervous System (CNS) malignancy
- •Have undergone allogeneic stem cell transplant and were treated with immunosuppressing agent within the past 6 months
- •Active Graft-versus-host disease (GVHD)
- •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
To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.
时间窗: Throughout the study
次要结局
- To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies.(Throughout the study)
- To assess the pharmacokinetic and pharmacodynamic profile of SB1518.(Throughout the study)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Trial to Determine MTD of BI 836845 Administered Intravenously Once Every Three Weeks in Patients With Advanced Solid Tumours and Later a Weekly Dosing Schedule in Selected Tumour TypesNeoplasmsNCT01317420Boehringer Ingelheim64
已完成
1 期
Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological MalignanciesHematologic MalignanciesChronic Myelogenous LeukemiaNCT00660920Ariad Pharmaceuticals81
已完成
1 期
An A/B Dose Escalation Study of AbGn-7 Alone and With FOLFOX7 Treatment in Patients With Advanced Solid TumorsSolid Tumor of Epithelial OriginGastric CancerNCT01466569AbGenomics B.V Taiwan Branch13
已完成
1 期
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced AlopeciaNCT01588522BPGbio28
招募中
1 期
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.Advanced Solid TumorsNCT05867420AskGene Pharma, Inc.594