NCT00343564已完成1 期
A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients With Non-Hodgkin Lymphoma and Hodgkin Lymphoma
Cytokinetics8 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.
研究概览
简要总结
This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the study was not initiated.
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
- •Phase 1: Patients with evaluable or measurable (by MRI or CT) Hodgkin's Disease or Non-Hodgkin's Lymphoma. Phase 2: Patients with Measurable Non-Hodgkin's Lymphomas (Indolent or Aggressive) only. - Patients with Indolent NHL must be relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil or fludaribine). Prior treatment with Rituximab is required. - Patients with Aggressive NHL refractory to (or relapsed from) at least one CHOP-based therapy who have had prior treatment with Rituximab and who are not candidates for high-dose chemotherapy or autologous stem cell transplantation. - ECOG performance status 0-2 - Autologous stem cell transplant recipients are eligible if 100 days have elapsed since procedure.
排除标准
- •Phase 1: History of prior radioimmunotherapy (Bexxar, Zevalin); These patients ARE permitted in the Phase 2 trial. - Current active malignancy besides NHL, except excised non-melanoma skin cancer, in-situ cervical or bladder cancer or early stage prostate cancer. - Patients with leptomeningeal of CNS lymphoma - Known allergy to and/or receipt of treatments contraindicated by administration of G-CSF - Patients with active Hepatitis B or C, or patients with HIV infection. - Pregnant or breast-feeding females. - Previous treatment with a KSP inhibitor
研究组 & 干预措施
Phase 1 Dose Escalation
Experimental
Phase 1 dose escalation without and with GCSF support
干预措施: SB-743921 (Drug)
Phase 2 Fixed Dose
Experimental
Phase 2 fixed dose based on Phase I findings stratified by NHL type
干预措施: SB-743921 (Drug)
结局指标
主要结局
Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.
时间窗: 28 days
Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).
次要结局
- Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
- Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15(Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose)
研究者
研究点 (8)
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