CTRI/2008/091/000004已完成1/2 期
An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma
Piramal Life Science7 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年2月2日最近更新:
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 7
- 主要终点
- Determination of maximaum tolerated dose of P276-00
研究概览
简要总结
This is an opel label phase I/II study in patients with relapsed and/or refractory multiple myeloma. Patients will be enrolled in cohorts of 3 each. Initial cohort will receive P276-00 at lowest dose of 50 mg/m2/day for 5 days per 21-day cycle. If the dose is well tolerated in the first cycle, then dose escalation will be performed for the next cohort. There will be no intra-patient dose escalation. Each patient will receive the treatment till objective evidence of progression of disease or till 6 cycles. Each patient will be evaluated for safety and efficacy. Dose limiting toxicities occurring during cycle 1 will be considered for dose escalation and for establishing MTD as described in the protocol. Once MTD is reached, up to ten additional patients may be enrolled to obtain further data on safety and efficacy of P276-00 at the MTD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy Monoclonal protein in the serum of greater than or equal to 1 g/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200 mg/ 24 hours, or measurable light chains by free light chain assay of greater than or equal to 10 mg/dL, or measurable plasmacytoma Age greater than or equal to18 years ECOG performance status less than or equal to 2 Life expectancygreater than or equal to 3 months Hemoglobin greater than or equal to8.0 gm/dL Absolute Neutrophil Count (ANC) greater than or equal to1000 cells/mm3 Platelets countgreater than or equal to 50,000/mm3 SGOT/AST less than 3.0 x institutional upper limits of normal Serum SGPT/ALT less than 3.0 x institutional upper limits of normal Serum creatinine less than 2.5mg/dL Serum total bilirubin less than 1.5 x institutional upper limits of normal Woman of childbearing potential with a negative serum pregnancy test.
- •In addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like G-CSF in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade less than or equal to 1) from adverse effects of such therapy received prior to 4 weeks Subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.
- •History of allergic reactions attributed to compounds of similar chemical composition to P276-
- •Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
- •Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years.
- •Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, cardiac ejection fraction 40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or nursing Subjects known to be seropositive for the human immunodeficiency virus or any history or evidence from physical examination of HIV infection.
- •Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP).
结局指标
主要结局
Determination of maximaum tolerated dose of P276-00
时间窗: end of the study
Characterization of dose limiting and other toxicities of P276-00
时间窗: end of the study
次要结局
- To determine pharmacokinetics of P276-00(To evaluate clinical response of P276-00)
研究者
研究点 (7)
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