NL-OMON34474已完成不适用
A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function - PK of panobinostat in psolid tumors and hepatic impairment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. ECOG performance status * 2
- •2. Documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
- •3. Baseline laboratory results
- •a. Absolute neutrophil count (ANC) * 1.5 x 109 /L
- •b. Platelet count * 100 x 109 /L
- •c. Serum creatinine * 1.5 x ULN
- •d. Serum potassium, magnesium, sodium, total calcium within normal limits
- •4. Mandatory use of double barrier method of contraception during the course of the study and for 3 months after completing study
- •5. Normal or abnormal hepatic organ function as defined in table 4-1 in the protocol
排除标准
- •1. Prior treatment with DAC inhibitors including panobinostat
- •2. Patient needing valproic acid during the study or within 5 days prior to first panobinostat dose
- •3. Concomitant anti-cancer therapy
- •4. Diuretics: potassium sparing diuretics are allowed
- •5. Active CNS disease or brain metastasis, except those previously treated and stable for at least 3 months
- •6. Evidence of another malignancy not in remission or history of such a malignancy within the last 3 years (except for treated basal or squamous cell carcinoma or in situ cancer of the cervix)
- •7. The following therapies:
- •a. prior chemotherapy * 3 weeks prior to start
- •b. biologic immunotherapy including monoclonal antibodies or experimental therapy * 4
- •weeks prior to start
- •c. radiation therapy * 4 weeks or limited field radiotherapy * 2 weeks prior to start
- •d. therapy-related toxicities to * CTCAE grade 1 at baseline, with the exception of alopecia
- •8. major surgery * 2 weeks prior to starting study drug
- •9. Unresolved diarrhea * CTCAE grade 2
- •10. Impaired cardiac function, including any one of the following:
- •a. LVEF < the lower limit of institutional norm
- •b. a permanent cardiac pacemaker
- •c. congenital long QT syndrome
- •d. ventricular tachy-arrhythmias
- •e. resting bradycardia (< 50 beats / minute)
- •f. QTcF > 450 msec on screening ECG
- •g. Complete left bundle branch block (LBBB), bifascicular block (RBBB with either left anterior hemiblock or left posterior hemiblock)
- •h. Any clinically significant ST segment and/or T-wave abnormalities
- •i. Presence of unstable atrial fibrillation (ventricular response rate > 100 bpm).
- •j. Myocardial infarction or unstable angina pectoris * 6 months prior to starting studydrug
- •k. Congestive heart failure (New York Heart Association class III-IV)
- •l. Other clinically significant heart disease and vascular disease (e.g. uncontrolled hypertension)
- •11. Medications with relative risk of prolonging the QT interval or inducing torsade de pointes
- •12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat
- •13. Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause, uncontrolled thyroid dysfunction) that could cause unacceptable safety risks
- •14. A known history of HIV seropositivity (test for screening is not required)
- •15. Patient has ascites requiring intervention
- •16. Patient has hepatic encephalopathy
- •17. use of warfarin
- •18. Use of CYP3A4/5 inhibitors
研究者
相似试验
已完成
不适用
A phase I, open-label, multi-center study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal functiopharmacokinetic of panobinostat in solid tumors with varying degrees of renal function10027655NL-OMON36258ovartis10
进行中（未招募）
不适用
Pharmacokinetics and Safety of Solithromycin Capsules in paediatric subjects.EUCTR2014-004041-26-Outside-EU/EEACempra Pharmaceuticals , Inc64
进行中（未招募）
1 期
Phase 1 study of KCMC-001 for multidrug-resistant pulmonary tuberculosis resistant to chemotherapeutic agents INH and RFPpulmonary tuberculosisJPRN-jRCT2053190023Tsuyuguchi Kazunari6
招募中
1 期
Satoreotide Theranostic Pilot study in Extensive Stage in Small Cell Lung Cancer (ES-SCLC)Extensive Stage Small Cell Lung CancerCancer - Lung - Small cellACTRN12623000185662Ariceum Therapeutics Australia Pty Ltd70
已完成
不适用
A Phase 1, Open-Label, Multicenter Study to Evaluate Relative Bioavailability, Pharmacokinetics, Dose Proportionality, Food Effect After Single-Dose Administration of JNJ-67953964 (aticaprant) in Healthy Adult Participants Using reference and concept Formulations.mood disorder10027946depressionNL-OMON50169Janssen-Cilag80