EUCTR2011-001914-33-GB进行中（未招募）1 期
A phase 1/2a, dose escalation study of CHR-3996 in combination with tosedostat in subjects with relapsed, refractory multiple myeloma - MUK three
niversity of Leeds0 个研究点目标入组 27 人开始时间: 2011年8月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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
- •Able to give informed consent and willing to follow study protocol
- •Aged over 18
- •Subjects with multiple myeloma, who have failed conventional treatment regimens, and currently require further treatment due to relapse or non-response
- •ECOG Performance Status =2
- •Required laboratory values within 14 days of registration:
- •oAbsolute neutrophil count =1.0 x 10^9/L. Growth factor support is permitted
- •oPlatelet count =25 x 10^9/L. Platelet support is permitted
- •oHaemoglobin =8.0 g/dL. Blood support is permitted
- •oBilirubin =2 times upper limit of normal (ULN)
- •oAST and ALT =2.5 times ULN; except in subjects with known hepatic involvement, where AST and ALT =5.0 times ULN
- •oSerum creatinine =2.0 times ULN
- •oCorrected calcium =2.8 mmol/L.
- •Anticipated survival of at least 4 months
- •Evaluable disease utilising the following assessments as appropriate:
- •oMeasurement of serum monoclonal protein.
- •oMeasurement of serum free light chains.
- •oMeasurement of urine M protein (Bence Jones protein) (differential creatinine).
- •oDetection of plasma cells in bone marrow biopsy or aspirate sample.
- •Female subjects of child-bearing potential must have a negative pregnancy test at baseline and agree to use dual methods of contraception for the duration of the study. Male subjects must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of child-bearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Pregnant (positive pregnancy test) or breastfeeding women.
- •Patients with high urinary light chain levels (=1g/24 hours). (Where urinary light chain levels are unavailable, serum free light chain levels =1000mg/L)
- •Previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics within 28 days before the start of treatment.Steroid therapy to stop rapid relapse during this period is permitted, but must be stopped 7 days prior to study drug administration. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted.
- •Concurrent or previous malignancies (<12 months post end of treatment) at other sites with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (=12 months) of other tumours may be entered.
- •A Poorly uncontrolled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical study.
- •Patients with significant cardiovascular disease (e.g. history of congestive heart failure requiring therapy, presence of severe valvular heart disease, presence of an atrial or ventricular arrhythmia requiring treatment, uncontrolled hypertension, a history of QTc abnormalities or with QTcF intervals >450 msec)
- •Active symptomatic fungal, bacterial, and/or viral infection including active HIV or viral (A, B, or C) hepatitis.
- •Gastrointestinal disorders that may interfere with absorption of the study drug
- •Abnormal plasma potassium, calcium or magnesium levels (CTCAE v4 grade 3 or greater) despite therapy
研究者
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