EUCTR2012-000326-22-GB进行中（未招募）1 期
A PHASE I/II DOSE ESCALATION TRIAL OF HDAC INHIBITOR TEFINOSTAT (CHR-2845) FOR CANCER ASSOCIATED INFLAMMATION IN HEPATOCELLULAR CARCINOMA - CHR258 in HCC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
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.Histologically or cytologically confirmed malignant HCC refractory to standard therapy or for which no standard therapy exists.
- •a.Patients with alcoholic cirrhosis may be included dependent on clinical judgement as to their ability to conform to the protocol
- •3.Patient is not a transplant candidate
- •4.Recovered from all acute adverse effects of prior therapies
- •5.Hepatitis is controlled by antiviral therapy (PEG-IFN, ribavirin, telaprevir, etc). Prophylactic Lamivudine for HBV carriers.
- •6.Child-Pugh classification A or B7.
- •7.Adequate bone marrow, hepatic and renal function including the following
- •a.Hb = 9.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelets =75 x 109/L
- •b.Total bilirubin = 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
- •c.AST (SGOT), ALT (SGPT) = baseline + 4 x upper normal limit
- •d.Creatinine = 1.5 x upper normal limit
- •e.Serum albumin > 28 g/L
- •f.INR < 1.5 or a Pt/PTT within normal limits
- •6.Age = 18 years
- •7.Performance status (PS) 0-2 (ECOG scale)
- •8.Estimated life expectancy greater than 3 months
- •9.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 pessary)
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1.Anti-cancer therapy including chemotherapy, radiotherapy, TACE, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial.
- •2.Use of medicines known to prolong QTc within 14 days prior to the first dose of study drug
- •3.Candidate for surgical resection, orthotopic liver transplantation, or loco-regional therapy such as radio-frequency ablation or chemoembolization
- •4.History of organ allograft
- •5.Co-existing active infection or serious concurrent illness
- •6.Significant cardiovascular disease as defined by
- •a.history of congestive heart failure requiring therapy
- •b.history of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry
- •c.presence of severe valvular heart disease
- •d.presence of a ventricular arrhythmia requiring treatment
- •e.LVEF < 50% (or less than institutional norm– some places have 45%)
- •f.QTc interval =450 ms for men and =470 ms for women (using Bazett’s formula)
- •7.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
- •8.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- •9.Gastrointestinal disorders that may interfere with absorption of the study drug.
- •10.Patients requiring palliative radiotherapy within the last 4 weeks of study entry
- •11.Uncontrolled hypercalcaemia (>CTCAE v4.0 grade I)
- •12.Pregnant or breast-feeding women
- •13.Patients who have received an investigational drug within the last 4 weeks
研究者
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