EUCTR2005-004230-40-ES进行中（未招募）不适用
A Phase 1/2 Study of SKI-606 in Philadelphia Chromosome Positive LeukemiasEstudio de Fase 1/2 de SKI-606 en Leucemias con Cromosoma Filadelfia Positivo.
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 120 人开始时间: 2006年1月20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
- 120
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) Cytologic or PCR based diagnosis of any phase of Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.
- •a. Intolerant is defined as subjects unable to take imatinib due to grade =3 toxicity or persistent grade 2 toxicity that is not responding to adequate supportive treatment and/or imatinib dose adjustments.
- •b. Relapsed disease will include subjects who have failed to maintain a major cytogenetic response, or failed to maintain any hematologic response.
- •c. Refractory is defined as subjects who fail to achieve adequate response while taking full-dose imatinib. (see #3 for adequate responses)
- •d. In the case that a subject progresses on less than full-dose imatinib, (but at least 300mg daily, or lower if combined with chemotherapy), and cannot receive a higher dose of imatinib due to previous toxicity thought to be due to imatinib, that subject will be eligible for this study.
- •2) Duration of imatinib treatment must conform to the following:
- •a. Subjects started on imatinib in chronic phase who fail to achieve or have failed to maintain a CHR after 12 weeks of full-dose therapy, any cytogenetic response by 26 weeks, or a major cytogenetic response by 12 months. Subjects previously confirmed as responses in any of these categories that have a confirmed loss of their response during the first year are eligible.
- •b. Any subject progressing from Chronic or better to Accelerated or Blast Phase after at least 4 weeks of imatinib treatment immediately qualifies for SKI-606 study inclusion.
- •c. Subjects started on imatinib in accelerated or blastic phase who fail to achieve a return to chronic phase by 12 weeks of imatinib at full dose (=600 mg/day) is eligible.
- •d. Ph positive Acute Lymphocytic Leukemia subjects who fail to attain remission by 8 weeks, or subsequently lose progress from a state of remission.
- •3) ECOG Performance Status of 0 or 1 for Chronic Phase subjects, and 0,1 or 2 for Advanced Stage Subjects
- •4) At least 7 days since prior imatinib treatment
- •5) In part 1, no prior exposure to Src, Abl, or Src/Abl kinase inhibitors is allowed. In Part 2, a maximum of five subjects entering in Chronic Phase, and ten subjects entering in Advanced Phases with a history of any prior exposure to experimental Abl, or Src/Abl inhibitors will be allowed. Discussion of these subjects with the Global Medical Monitor must occur before patient dosing with SKI-606. In these cases at least 10 half lives or 21 days must have passed since previous Src, experimental Abl, or Src/Abl kinase inhibitor treatment, whichever is longer.After these 15 subjects have been enrolled, no prior exposure to Src, Abl or Src/Abl kinase inhibitors is allowed.
- •6) At least 21 days since any other anti-proliferative treatment, (Except Hydroxyurea & Anagrelide – see concomitant medications) including any other investigational agents. For subjects with advanced phase acute leukemia and rapidly progressing disease, this limit could be decreased to 2 weeks, after consulting with the Global Medical Monitor. In these cases, however, toxicities must be grade 1 or better to permit study inclusion and SKI-606 dosing.
- •7) Recovered to Grade 0-1, or to baseline, from any toxicities of prior treatment, other than alopecia
- •8) At least 4 months post stem cell transplantation
- •9) Adequate bone marrow function in Part 1
- •a. Absolute neutrophil c
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 6 months. Subjects with CNS symptoms must have a diagnostic lumbar puncture prior to study enrollment.
- •4) Subjects without evidence of leukemia in bone marrow (extramedullary disease only).
- •5) Ongoing requirement for warfarin (Part 1 only)
- •6) Ongoing requirement for hydroxyurea or anagrelide
- •7) Prior exposure to src or abl kinase inhibitors (other than imatinib) except in Part 2 as specified below: Up to five chronic phase and ten advanced phase (AP/BP/ALL) subjects with previous src/abl (other than SKI-606) will be allowed.
- •8) Major surgery or radiotherapy within 14 days before the first dose of SKI-606 (recovery from any previous surgery should be complete before day 1)
- •9) Ongoing clinical requirement for administration of a strong inhibitor of CYP-3A4
- •10) A history of ventricular arrhythmia, congenital or acquired prolonged QT interval, a baseline QTc > 0.45 sec or unexplained syncope
- •11) Concomitant use of or need for medications known to prolong the QT interval
- •12) Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
- •13) 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)
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