PER-081-07已完成未知
A Phase 1/2 Study of SKI-606 in Philadelphia Chromosme Positive Leukemias
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Informed consent form approved by the Institutional Review Board (IRB) or by the Independent Ethics Committee (IEC), dated and signed, before carrying out any of the screening procedures specified in the protocol.
- •Cytogenetic or PCR-based diagnosis of any phase of Ph CML or Ph ALL whose disease is resistant to the full dose of imatinib (> 600 mg), or has intolerance to any dose of imatinib. (See section 10.1.2 for definitions of resistant and intolerant)
- •Adequate duration of a previous therapy with imatinib
- •ECOG performance status of O or 1 for the subjects that are in the chronic phase, and 0.1 or 2 for the subjects in the advanced stage.
- •At least 7 days from any anti-proliferative treatment, (except hydroxyurea & anagrelide - see Concomitant treatment - Permitted medications for more details).
- •Recovered to Grade 0-1, or at baseline, from any of the toxicities of the previous treatment, other than alopecia
- •At least 3 months of allogeneic stem cell transplantation
- •Able to take daily oral capsules reliably
- •Adequate function of the bone marrow (subjects in chronic phase only - Part 1 only)
- •Adequate renal and hepatic function
- •Age> 18 years
- •Disposition of male and female subjects, who are not sterile surgically or post-menopausal, to use reliable methods for birth control (oral contraceptives, intrauterine devices or barrier methods used with spermicide) for the duration of the study and for 30 days after the last dose of SKI- 606.
- •Normal documented INR if you are not on an oral anticoagulant therapy (OAT), or if you are at a consistent OAT goal INR <3.
排除标准
- •Subjects with CML negative to the Philadelphia chromosome and to bcr-abl.
- •Subjects with prior imatinib intolerance - Part 1 (increase in dose only)
- •Explicit leptomeningeal leukemia. Subjects should not have a CNS complication for a minimum of 2 months. Subjects with symptoms of CNS complication should undergo a diagnostic lumbar puncture before being enrolled in the study.
- •Subjects with extramedullary disease only.
- •Part 1 does not allow prior exposure to inhibitors of Src, Abl, or Src / Abl kinases.
- •Ongoing warfarin or other OAT requirement (Part 1 only)
- •Ongoing hydroxyurea or anagrelide requirement (Part 1 only)
- •Graft versus Host Disease (GVHD)
- •Part 1 - prior GVHD is not allowed
- •Part 2 - without GVHD treated or not treated within 60 days of the start of the study
- •Major surgery within 14 days or radiation therapy within 7 days before the first dose of SKI-606 (recovery from any previous surgery must be completed before day 1)
- •Clinical requirement for the administration of a strong CYP-3A4 inhibitor - Part 1 only
- •History of a clinically significant ventricular arrhythmia, congenital or acquired QT interval, baseline QTcF> 0.47 sec (average of triplicate readings) or unexplained syncope, symptomatic or uncontrolled congestive heart failure (CHE) within 3 months, or myocardial infarction (MI) within 6 months.
- •Concomitant use or need to use medications known to prolong the QT interval
- •Hypomagnesemia or uncorrected hypokalemia due to possible effects on the QT interval.
- •Recent gastrointestinal disorder (within 30 days of admission to the study) or current with clinical significance (eg malabsorption, small bowel syndrome, bleeding, or emesis, nausea or diarrhea grade> 1 with a duration greater than 2) days, despite adequate medical treatment)
- •Women who are pregnant or breastfeeding
- •Evidence of serious active infection, or significant medical or psychiatric illness
- •Known seropositivity for HIV, or Hepatitis B or current or chronic acute hepatitis C (positive antigen), cirrhosis, hypokalemia (any degree), or an abnormal laboratory result with clinical significance that, in the investigator´s judgment, would make the subject was appropriate to participate in this study.
研究者
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