EUCTR2005-004955-36-DE进行中（未招募）不适用
A Phase I-II Study to Evaluate the Safety, Tolerability and Anti-Disease Activity of the Aminopeptidase Inhibitor, CHR-2797, in Elderly and/or Treatment Refractory Patients with Acute Myeloid Leukaemia or Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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.Signed, informed consent.
- •2.Patients with AML, MDS (subtype RAEB-1 or RAEB-2), or MM whose disease has relapsed or is refractory to front line and/ or salvage therapy; elderly patients (= 60 years) with AML, MDS, MM who are not candidates for chemotherapy and for whom other therapy is inappropriate*.
- •3.Patients should have recovered from the acute adverse effects of prior therapies (excluding alopecia and grade II neuropathy).
- •4.AML, MDS and MM are diseases of the haematopoetic system and can cause myelosuppression. Consequently supportive should be given to ensure adequate values, according to local guidelines.
- •5.A bone marrow aspirate/ biopsy performed within four weeks prior to study entry.
- •6.Adequate bone marrow, hepatic and renal function including the following:
- •a.Patients with high blast counts can be included in the trial, if they can be controlled by the use of hydroxyurea (500-3000 mg daily).
- •b.Total bilirubin = 1.5 x upper normal limit.
- •c.AST (SGOT), ALT (SGPT) = 2.5 x upper normal limit.
- •d.Creatinine =1.5 x upper normal limit.
- •7.Age = 18 years
- •8.Performance status (PS) = 2 (ECOG scale).
- •9.Estimated life-expectancy greater than 3 months.
- •10.Female patients with with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of the trial. A woman with reproductive potential is defined as one who is biologically capable of becoming pregnant. Patients who are not surgically sterile or postmenopausal must agree to use a medically acceptable and highly effective method of birth control for the duration of the study and to continue after the end of CHR-2797 treatment for a further 3 months (female patients) or for a further 6 months (for male patients and their partners). A highly effective method of birth control is defined as any method that results in a low failure rate, including implants, injectables, some intra-uterine devices (IUD’s), sexual abstinence, and vasectomy/ sterilization. Sexually active males and females using oral contraceptive pills should also use barrier contraception. Although there is no reason to believe that the use of CHR-2797 has an effect on the pharmacokinetics of hormonal contraceptives, this has not yet been proven.
- •* There will be a clinical conference after completion of phase I to decide on patient population for phase II: AML/MDS or MM or both.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry- except for hydroxyurea (maximum daily dose is 3 g).
- •2.Indolent, smouldering myeloma, monoclonal gammopathy with unknown
- •significance.
- •3.Patients who need a daily dose of hydroxyurea greater than 3 g to control leukocytosis.
- •4.Co-existing active infection or serious concurrent illness.
- •5.Any co-existing medical condition that in the investigator’s judgement will
- •substantially increase the risk associated with the patient’s participation in the study.
- •6.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.
- •7.Gastrointestinal disorders that may interfere with absorption of the study drug.
- •8.Patients with platelet count(s) less than 20,000.
- •9.Patients who have had a blood transfusion (platelet support or packed cells) within 7 days prior to study entry.
- •10.Persistent grade II or greater toxicity from any cause (except haematological toxicities and peripheral neuropathy).
- •11.Patients with grade III–IV peripheral neuropathy.
- •12.Pregnant or breast-feeding women.
研究者
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