A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 123
- 主要终点
- Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity.
研究概览
简要总结
The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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, either sex, any race.
- •Eastern Cooperative Oncology Group performance status of 0, 1, or
- •There must be no known standard therapy, or disease must be refractory to standard therapy
- •Adequate hematologic, renal, and hepatic organ function and laboratory parameters
- •For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
- •Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
- •Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH
- •Subjects with multiple myeloma must have measurable disease defined as:
- •Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
- •Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:
- •serum free light chain ratio greater than 5 times the normal ratio limit; and/or
- •measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or
- •bone marrow involvement greater than 30%.
- •For B-cell chronic lymphocytic leukemia (B-CLL):
- •Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.
- •Disease must be evaluable according to NCI-WG response criteria.
排除标准
- •Symptomatic brain metastases or primary central nervous system malignancy.
- •Previous radiation therapy to >25% of the total bone marrow.
- •Previous treatment with SCH
- •Known HIV infection.
研究组 & 干预措施
Advanced solid tumors
Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts
干预措施: SCH 727965 (Drug)
Non-Hodgkin's lymphoma and multiple myeloma
Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965
干预措施: SCH 727965 (Drug)
B cell chronic lymphocytic leukemia
Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts
干预措施: SCH 727965 (Drug)
结局指标
主要结局
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity.
时间窗: End of trial
In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
时间窗: End of trial
次要结局
未报告次要终点