EUCTR2018-004878-99-IT进行中（未招募）1 期
An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants - NA
INCYTE BIOSCIENCES INTERNATIONAL SàR0 个研究点目标入组 60 人开始时间: 2021年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Histologically or cytologically confirmed diagnosis of the following
- •malignancies:
- •a. Phase 1:
- •- CP-CML, BP-CML, AP-CML (relapse).
- •- Other leukemias.
- •- Lymphoma.
- •- Any other tumors, including tumors of the CNS, for which standard
- •therapy is not available or is not indicated.
- •b. Phase 2, Group A with CP-CML:
- •- CP-CML at the time of study entry and must be resistant to or
- •intolerant of at least 1 prior BCR-ABL–targeted TKI therapy or have the
- •T315I kinase domain mutation.
- •- Must have 1 bone marrow aspirate with documentation of BCR-ABL
- •translocation by conventional cytogenetics, metaphase FISH, or q-PCR
- •performed within 42 days before the first dose of ponatinib.
- •c. Phase 2, Group B with other leukemias or solid tumors:
- •- Other leukemias.
- •- Lymphoma.
- •- Any other tumors, including tumors of the CNS, with mutations of RET,
- •KIT, FGFR, PGFR, VEGFR, or any other mutations where ponatinib may
- •have biological activity on fresh or archived tumor tissue.
- •- Participants with solid tumors or with lymphoma must have
- •XML File Identifier: mNBpTemDDjlGLhs1x2qqTgzLru8=
- •measurable disease by CT or MRI based on RECIST v1.1 or the Lugano
- •lymphoma guidelines (Cheson et al 2014) as determined by site
- •Note: Lesions situated in a previously irradiated area are considered
- •measurable if progression has been demonstrated in such lesions.
- •2. Prior therapies as follows:
- •a. Phase 1:
- •- Participants with CML who are resistant to or intolerant of to at least 1
- •prior BCR-ABL–targeted TKI therapy.
- •- Participants with ALL who have failed all available or indicated
- •therapies, which may have included 1 prior BCR-ABL–targeted TKI
- •- Participants with AML or other leukemias who have failed at least 1
- •prior induction attempt or for whom no effective standard therapy is
- •available or indicated.
- •- Participants with solid tumors (including tumors of the CNS) or
- •lymphomas who have progressed despite standard therapy or for whom
- •no effective standard therapy is available or indicated.
- •b. Phase 2, Group A with CP-CML:
- •- Participants who are resistant to or intolerant of at least 1 prior BCRABL–
- •targeted TKI therapy.
- •c. Phase 2, Group B with other leukemias or solid tumors:
- •- Participants with ALL who have failed all available or indicated
- •therapies, which must have included 1 prior BCR-ABL–targeted TKI
- •- Participants with AML or other leukemias who have failed at least 1
- •prior induction attempt or for whom no effective standard therapy is
- •available or indicated.
- •- Participants with solid tumors (including tumors of the CNS) or
- •lymphomas who progressed despite standard therapy or for whom no
- 另有 11 项未显示
排除标准
- •1. Participants with CP-CML who are in MCyR or better.
- •2. Prior therapies:
- •a. Participants with BP-CML, ALL, or AML who have received any of the
- •- Corticosteroids or hydroxyurea within 24 hours before the first dose of
- •- Vincristine within 7 days before the first dose of ponatinib.
- •- Other chemotherapy (excluding intrathecal chemotherapy) within 14
- •days before the first dose of ponatinib.
- •b. Participants (except the BP-CML, ALL, and AML participants described
- •above) who:
- •- Have had cytotoxic chemotherapy or radiotherapy within 21 days (or
- •42 days for nitrosoureas or mitomycin C) before the first dose of
- •c. Prior radiation therapy within 6 weeks or radio-isotope therapy within
- •6 weeks before the first dose of ponatinib.
- •d. Autologous or allogeneic stem cell transplant < 3 months before the
- •first dose of ponatinib.
- •e. Major surgery within 14 days before the first dose of ponatinib.
- •Note: Minor surgical procedures, such as central venous catheter
- •placement or bone marrow aspirate/biopsy, are permitted.
- •f. Inadequate recovery and/or complications from a major surgery
- •before starting therapy.
- •g. Prior treatment with any of the following:
- •- Immunosuppressive therapy (including post stem cell transplant
- •regimens) within 14 days before the first dose of ponatinib.
- •- Any targeted cancer therapy (including TKIs) within 7 days before the
- •first dose of ponatinib.
- •- Any other investigational anticancer agents within 30 days or 5 halflives,
- •whichever is longer, before randomization.
- •- Any monoclonal antibody–directed anticancer therapy within 5 halflives
- •of the first dose of ponatinib.
- •- Any chimeric antigen receptor therapy within 28 days before the first
- •dose of ponatinib
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