ACTRN12618001934235招募中1 期
A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in children with advanced brain and solid tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Years 至 21 Years（—）
- 性别
- All
入选标准
- •1.All patients and/or their parents or legal guardians must give voluntary written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- •2.Aged =/> 1year and =/> 21 years old at the time of study enrolment.
- •3.Karnofsky =/> 50% for patients > 16years of age and Lansky =/> 50% for patients =/> 16 years of age.
- •a.Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrolment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
- •b.Patients receiving corticosteroids must be on a stable dose that has not been increased for at least 7 days prior to study enrolment
- •4.For Part A: Have relapsed or refractory solid or CNS tumors or have a diagnosis of DIPG or Diffuse Midline H3 K27M glioma.
- •5.For Part B: Patients must have a diagnosis of DIPG or Diffuse Midline H3 K27M glioma following treatment with radiation therapy; OR recurrent or refractory high grade glioma.
- •6.Have either measurable or evaluable disease for Part B of the study only.
- •7.Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
- •8.Have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- •9.Myelosuppresive chemotherapy: Must not have received within 3 weeks of enrolment onto this study (6 weeks if prior nitrosourea).
- •10.Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. PEG-CGSF) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
- •11.Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
- •12.Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
- •13.XRT: =/> 6 weeks since administration of radiation therapy; =/> 24 weeks must have elapsed if prior TBI.
- •14.MIBG therapy: At least 6 weeks must have elapsed since the completion of radio-labelled MIBG therapy.
- •15.Stem cell transplant or rescue, including autologous cell transplant: No evidence of active graft vs. host disease and =/> 12 weeks must have elapsed.
- •16.Haematological function as follows:
- •Absolute neutrophil count (ANC) =/> 1.0 x 109/L;
- •Platelet count =/> 50 x 109/L (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrolment);
- •Lymphocyte count =/> 0.5 x 109/L;
- •Haemoglobin =/> 80 g/L (may receive RBC transfusions);
- •Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN).
- •17.Adequate Renal function defined as:
- •Creatine clearance or radioisotope GFR =/> 70ml/min/1.73 m2
- •A serum creatinine based on age/gender as follows:
排除标准
- •1.Pregnant or breast-feeding women.
- •2.Any active uncontrolled infection.
- •3.Disease of any major organ system that would compromise their ability to withstand therapy.
- •4.Pre-existing allergy to ACT001 or related compounds.
- •5.History of infection with HIV or hepatitis B or C viruses.
- •6.Concurrent or prior (within 7 days of enrolment) anticoagulant therapy, except low molecular weight heparins or low dose aspirin.
- •7.Patients currently receiving another investigational drug.
- •8.Patients currently receiving other antineoplastic agents
- •9.All herbal supplements, vitamins, and nutritional supplements taken within the last 30 days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed and approved by the Investigator.
- •10.Will not be available for protocol-required study visits or procedures, to the best of the patient/parent/guardian’s and investigator’s knowledge.
- •11.Any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient/parent/guardian to give written informed consent and/or to comply with all required study procedures.
- •12.History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion.
研究者
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