EUCTR2008-005542-23-GB进行中（未招募）1 期
A CCLG/Cancer Research UK Phase I Trial of AT9283 (a selective inhibitor of Aurora kinases) given for 72 hours every 21 days via intravenous infusion in children and adolescents with relapsed and refractory solid tumours. - Phase I paediatric study of AT9283 in solid tumours.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
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 proven solid tumour refractory to conventional treatment, or for which no conventional therapy exists.
- •Diffuse Intrinsic Pontine Gliomas that have progressed or relapsed after first line therapy can be included without histological verification if they fulfill the following criteria:
- •At the time of diagnosis a diffuse intrinsic lesion centred in the pons on MRI imaging with a clinical history of <6 months.
- •Diagnostic clinical findings at first presentation must have included at least one of the following three signs of brainstem tumour: (i) cranial nerve deficit (ii) long tract signs, (III)ataxia
- •2. Life expectancy of at least 12 weeks.
- •3. World Health Organisation (WHO) performance status of 0, 1, or 2 or Lansky Play scale = 70% (a lower score may be acceptable if it is due to a stable neurological deficit and for patients with CNS tumours)
- •4. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day -1) before the patient goes on study.
- •Laboratory Test Value required
- •Haemoglobin (Hb) =9.0 g/dl
- •Absolute neutrophil count =1.0 x 10(9)/L
- •Platelet count =100 x 10(9)/L
- •Creatinine Kinase Serum bilirubin <1.5 x upper limit of normal (ULN)
- •Alanine amino-transferase (ALT) or aspartate amino-transferase (AST) < 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible
- •EDTA or DTPA measured Glomerular Filtration Rate (GFR)=60 ml/min/1.73 m2
- •5. Aged >2 to <19 years
- •6. In the investigators opinion, patient has sufficient blood volume to undergo the blood sampling regimen specified by the protocol without jeopardising patient safety.
- •7. Written (signed and dated) informed consent from patient and / or parent or legal guardian and be capable of co-operating with treatment and follow-up
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous 4 weeks (6 weeks for investigational medicinal products; 2 weeks for vincristine) before treatment.
- •Steroids: Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
- •2. Prior exposure to an Aurora kinase inhibitor.
- •3. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the Centre for Drug Development (CDD) should not exclude the patient.
- •4. Pregnant or lactating women are excluded. Female patients with the ability to become pregnant who have a negative serum or urine pregnancy test before enrolment and agree to use two of the following three highly effective forms of combined contraception (oral, injected or implanted hormonal contraception and condom, have a intra-uterine device and condom, diaphragm with spermicidal gel and condom) for four weeks before entering the trial, during the trial and for six months afterwards are considered eligible.
- •5. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] during the trial and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
- •6. Major thoracic or abdominal surgery from which the patient has not yet recovered.
- •7. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- •8. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- •9. Fractional shortening of < or = 29% on Echocardiogram
- •10. LVEF of <50%
- •11. History of allergy or auto-immune disease*.
- •12. Congenital heart disease.
- •13. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow.
- •14. Stem Cell Transplant (SCT): Patients who have undergone an autologous stem cell transplant must be greater than three months from the date of the stem cell return.
- •15. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
- •16. Is a participant or plans to participate in another interventional clinical study, whilst taking part in this Phase I study of AT9283. Participation in an observational study would be acceptable.
- •*this criterion is intended to exlude only those patients with a clinically significant history of allergy or auto-immune disease.
研究者
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