EUCTR2016-004554-14-Outside-EU/EEA进行中（未招募）1 期
A Phase 1, Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients with Relapsed or Refractory Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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. Patient and/or guardian have signed an Informed Consent Form and Assent approved by the Institutional Review Board or Institutional Ethics Committee, as appropriate and necessary, on a per-age basis
- •2. Age 6 months to 21 years old (initial qualifying diagnosis must have been made at or before the age
- •of 18 and the patient must be under the care of a pediatric hematologist/oncologist)
- •3. Patient received a diagnosis of lymphoma or any non-hematologic malignancy (except central nervous system [CNS] tumors) for which the patient is considered relapsed or refractory. (NOTE: CNS metastases are allowable in patients who are deemed not at risk for progression during the first 30 days, who are neurologically stable, and, if on corticosteroids, have been on a stable corticosteroid dose for at least 2 weeks.) Patients who have >1 malignancy ongoing during screening are not eligible
- •4. Patient must have one or more of the following treatment statuses:
- •Has failed at least 2 prior lines of chemotherapy
- •Has no curative chemotherapy treatment option available
- •Is not considered a candidate for available chemotherapy treatment options
- •5. In dose-escalation accrual, patients may have un-measurable disease (such as bone marrow/bone involvement or diffuse tumors)
- •6. In dose-escalation accrual, patients may have un-measurable disease in cases where the standard of care would indicate the need for adjuvant chemotherapy after definitive surgery or radiation, but for whom no standard chemotherapy options are available
- •7. In expansion cohort accrual, patients must have disease that is evaluable or measurable for response and progression per standard criteria for their diagnosis (Refer to the Appendices: RECIST 1.1 Criteria for Evaluation of Solid Tumors, Including Neuroblastoma, Appendix 18.4], Evaluation of Neuroblastoma [Appendix 18.6], and the Lymphoma Staging and Disease Response Criteria [Appendix 18.5])
- •8. Karnofsky-Lansky performance status (as per age of patient) =50 (Appendix 18.1)
- •9. Patient must have one or more of the following cardiac function measurements by echocardiogram:
- •Left ventricular ejection fraction (LVEF) =55%
- •Left ventricular shortening fraction (LVSF) =27%
- •10. Hemoglobin =8 g/dL (can be post-transfusion)
- •11. Platelet count =75 × 109/L
- •12. Absolute neutrophil count (ANC) =0.75 × 109/L
- •13. Serum direct/conjugated bilirubin =1.5 × upper limit of normal (ULN); patients with clinically diagnosed Gilbert's syndrome and total bilirubin =5 × ULN may be enrolled
- •14. Aspartate aminotransferase (AST; also called serum glutamicoxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT; also called serum glutamic-pyruvic transaminase [SGPT]) =2.5 × ULN, or =5 × ULN if elevation is due to hepatic involvement by tumor
- •15. Serum creatinine =2 × ULN
- •16. Patients must meet the following criteria with respect to prior cancer therapy, radiotherapy, and
- •stem cell transplants:
- •a.Myelosuppressive chemotherapy: At least 3 weeks must have elapsed since the completion of myelosuppressive chemotherapy (4 weeks if prior nitrosourea) and resolution of all nonhematologic toxicities to = grade 1.
- •b.Biologic (anti-neoplastic agent):
- •Oral tyrosine kinase inhibitors or other similar agents. At least 7 days must have elapsed since the completion of therapy with a biologic agent and all non-hematologic toxicities must have resolved to =grade 1 prior to enrollment
- •Anti-IGFR-1R and other monoclonal antibodies: the shorter
排除标准
- •1. Investigator-predicted life expectancy of less than two months
- •2. Investigator-predicted inability to tolerate pixantrone monotherapy
- •treatment adverse effects for less than two months
- •3. Prior anthracycline treatment with a cumulative dose exceeding 450
- •mg/m2 (calculated based on doxorubicin equivalents; Appendix 18.3)
- •4. Active National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) =grade 3 infection, or a lower grade infection deemed resistant or refractory to available antimicrobial agents, or infection requiring ongoing antibiotic treatment
- •5. Major surgery =7 days and/or with incomplete/inadequate wound healing prior to start of study
- •6. Known acute or chronic hepatitis B or hepatitis C virus infection
- •7. Known seropositivity for human immunodeficiency virus (HIV)
- •8. Any experimental/investigational therapy =28 days prior to start of
- •study treatment
- •9. Myocardial infarction within the past 6 months
- •10. New York Heart Association class II, III or IV heart failure
- •11. Any contraindication, known allergy, or hypersensitivity to any
- •investigational drug(s)
- •12. Pregnant or lactating
- •13. Planned radiotherapy or surgical procedures for the qualifying malignancy
- •14. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study procedures or followup schedules
- •15. Other severe and/or uncontrolled medical disease that could compromise participation in the study, or any medical or psychiatric condition that, in the opinion of the investigator, would make pixantrone administration hazardous or obscure the interpretation of data
研究者
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