NL-OMON54589招募中2 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. - INCB 84344-102
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
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
- 年龄范围
- 0 至 17（—）
入选标准
- •1. Histologically or cytologically confirmed diagnosis of the following
- •malignancies:
- •a. Phase 1:
- •* CP-CML, BP-CML, AP-CML (relapse defined in Appendix G).
- •* 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 (defined in Appendix G) 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.
- •2. Prior therapies as follows:
- •a. Phase 1:
- •* Participants with CML who are resistant to or intolerant of (as defined
- •Appendix G) 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 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
- •* 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 (for other countries).
- 另有 6 项未显示
排除标准
- •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
- •* 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)
- •* Have had cytotoxic chemotherapy or radiotherapy 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 randomization.
- •* 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.
- •3. Participants with laboratory values at screening defined as follows:
- •Solid tumors
- •a Platelets <= 75 × 109/L
- •b Hemoglobin <= 8 g/L
- •c ANC <= 1 × 109/L
- •d ALT >= 5 × ULN for age (unless related to leukemic involvement)
- •e AST >= 5 × ULN for age (unless related to leukemic involvement)
- •f Direct bilirubin >= 1.5 × ULN for age
- •g Amylase > 2 × ULN for age
- •h Lipase > 2 × ULN for age
- •i Serum creatinine OR Serum creatinine clearance > ULN for age based on
- •age/gender chart below:
- •Age (years) Maximum Serum Creatinine (mg/dL)
- •Male Female
- •1 to < 2 0.6 0.6
- 另有 17 项未显示
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