EUCTR2005-004955-36-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 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
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 and can cause myelosuppression; consequently supportive therapy should be given to ensure adequate values, according to local guidelines.
- •5.A bone marrow biopsy performed within four weeks prior to study entry.
- •6.Adequate bone marrow, hepatic and renal function including the following:
- •a.High blast counts are not an exclusion criteria and 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 (or 5 x ULN in the presence of liver metastases).
- •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 reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository).
- •* 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 platetlet count(s) < 20x10^9/L
- •9.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.
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