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临床试验/EUCTR2018-004878-99-NL
EUCTR2018-004878-99-NL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

Incyte Biosciences International Sàrl0 个研究点目标入组 85 人开始时间: 2019年9月30日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
85
研究概览入排标准研究者记录与标识符相似试验

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
  • •- 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 or be in warning response status. Warning response status must a) be confirmed by at least 2 assessments performed at least 1 month apart and b) justify the change of treatment by comorbidities and tolerability.
  • •- 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, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity (eg. EPH receptors and SRC families of kinases) as assessed on fresh or archived tumor tissue.
  • •- Participants with solid tumors or with lymphoma must have measurable disease by CT or MRI based on RECIST v1.1 or the Lugano lymphoma guidelines (Cheson et al 2014) as determined by site radiology.
  • •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 progressed on or after all available or indicated therapies, which may have included 1 prior BCR-ABL–targeted TKI therapy.
  • •- Participants with AML or other leukemias who have progressed on or after at least 1 prior induction attempt (for France only) or for whom no effective standard therapy is available or indicated (for other countries).
  • •- 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 BCR-ABL–targeted TKI therapy.
  • •c. Phase 2, Group B with other leukemias or solid tumors:
  • •- Participants with ALL who have progressed on or after all available or indicated therapies, which must have included 1 prior BCR-ABL–targeted TKI therapy (exception for participants with T315I mutation) or are in warning status.
  • •- Participants with AML or other leukemias who have failed at least 1 prior induction attempt (for France only) or for whom no effective standard therapy is available or indicated (other countries).
  • •- Participants with solid tumors (including tumors of the CNS) or lymphomas who progressed despite standard therapy or for whom no effective standard therapy is available or indicated.
  • •3. Male and female participants = 1 to < 18 years old, inclusive, at the time of signing the informed consent.
  • •4. Karnofsky performance status = 40% for participants = 16 years old or Lansky Play Scale = 40% for pediatric participants < 16 years old.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 85
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Nu

排除标准

  • •Exclusion critirea: '1. Participants with CP-CML who are in MCyR or better' Removed during Protocol Amendment 1.
  • •2. Prior therapies:
  • •a. Participants with BP-CML, ALL, or AML who have received any of the following:
  • •- Corticosteroids or hydroxyurea within 24 hours before the first dose of ponatinib.
  • •- 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 within 21 days (or 42 days for nitrosoureas or mitomycin C) before the first dose of ponatinib.
  • •c. Prior radiation therapy or radio-isotope therapy before or radio-isotope therapy within 6 weeks before the first dose of ponatinib except local radiotherapy for palliative indication within 14 days before the first dose of ponatinib. For CNS, at least 90 days must have passed if the participant received prior total body irradiation or craniospinal or cranial radiotherapy.
  • •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 half-lives, whichever is longer, before first dose of ponatinib.
  • •- Any biotherapeutic (including monoclonal antibody–directed anticancer therapy within 5 half-lives or 30 days whichever is shorter, before of the first dose of ponatinib.
  • •Note: Supportive care medications for CNS edema (eg, stable doses of corticosteroids or bevacizumab) are permitted.
  • •- Any chimeric antigen receptor therapy within 28 days before the first dose of ponatinib

研究者

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