EUCTR2005-004230-40-FI进行中（未招募）不适用
A Phase 1/2 Study of SKI-606 in Philadelphia Chromosme Positive Leukemias - CML study
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 459 人开始时间: 2007年3月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 459
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed and dated institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures.
- •2. Cytogenetic or PCR based diagnosis of any phase of Ph+ CML or Ph+ ALL whose disease is resistant to full-dose imatinib (>/=600mg), or are intolerant of any dose of imatinib.
- •3. Adequate duration of prior imatinib therapy (See section 10.1.2)
- •4. ECOG Performance Status of 0 or 1 for chronic phase subjects, and 0, 1 or 2 for Advanced Stage subjects.
- •5. At least 7 days prior to first dose of SKI 606 since any anti-proliferative or anti-leukemia treatment, (except hydroxyurea & anagrelide see Concomitant Treatment – Permitted Medications for details)
- •6. Recovered to Grade 0-1, or to baseline, from any toxicities of prior anticancer treatment, other than alopecia
- •7. At least 3 months post allogeneic stem cell transplantation
- •8. Able to take daily oral capsules or tablets reliably
- •9. Adequate bone marrow function (Chronic Phase resistant subjects only)
- •a. Absolute neutrophil count > 1000/mm^3 (>1x10^9/L)
- •b. Platelets >/= 100,000/mm^3 (>100 x 10^9/L), absent any platelet transfusions during the preceding 14 days
- •10. Adequate hepatic, and renal function
- •a. AST/ALT b. Total bilirubin c. Creatinine 11. Age >/= 18 years
- •12. Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of SKI-606
- •13. Documented normal INR if not on oral anticoagulant therapy (OAT), or if no OAT consistent target INRAre the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with Philadelphia chromosome and bcr-abl negative CML.
- •2. Subjects previously intolerant of imatinib - Part 1 (dose escalation only)
- •3. Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimum of 2 months. Subjects with CNS symptoms must have a diagnostic lumbar puncture prior to study enrolment.
- •4. Subjects with extramedullary disease only
- •5. In part 1, no prior exposure to Src, Abl, or Src/Abl kinase inhibitors is allowed.
- •6. Ongoing requirement for warfarin or other OAT (Part 1 only)
- •7. Ongoing requirement for hydroxyurea or anagrelide (Part 1 only)
- •8. Graft Versus Host Disease (GVHD)
- •a. part 1 - no previous GVHD allowed
- •b. Part 2 - no treated or untreated GVHD within 60 days of study start
- •9. Major surgery within 14 days or radiotherapy within 7 before the first dose of SKI-606 (recovery from any previous surgery should be complete before day 1)
- •10. Ongoing clinical requirement for administration of a strong inhibitor of CYP-3A4 (See attachment 3) - Part 1 only
- •11. A history of a clinically-significant or uncontrolled cardiac disease including:
- •· history of or active congestive heart failure
- •· uncontrolled angina or hypertension within 3 months
- •· myocardial infarction (within 12 months)
- •· clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
- •· diagnosed or suspected congenital or acquired prolonged QT syndrome
- •· unexplained syncope
- •· history of prolonged QTc
- •12. Prolonged QTc (>0.45 sec, average of triplicate readings at screening)
- •13. Concomitant use of or need for medications known to prolong the QT interval (See Attachment 4)
- •14. Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
- •15. Recent (within 30 days of study entry) or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding or Grade >1 diarrhea, nausea or emesis lasting more than 2 days, despite adequate medical therapy)
- •16. Pregnant or breastfeeding women
- •17. Evidence of serious active infection, or significant medical or psychiatric illness
- •18. Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, or clinically significant abnormal laboratory finding that would, in the investigator's judgment, make the subject imappropriae for this study.
- •19. Documented history of T315I Bcr-Abl mutation.
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