NL-OMON36258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 function - PK of panobinostat in solid tumors with varying renal function
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
- 10
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. Patient is * 18 years of age
- •2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of * 2
- •3. Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
- •4. Patient has the following laboratory values within 2 weeks of starting study drug (labs may be repeated, if needed, to obtain acceptable values before failure at screening is concluded)
- •a. Creatinine clearance according to a 24-hour urine CrCL (specific criteria for allocation of patients by renal function):
- •* * 80mL/min for the normal renal function patients
- •* *50 - <80 mL/min for the mildly renal impaired patients
- •* *30 - <50 mL/min for the moderately impaired patients
- •* < 30mL/min for severely renal impaired patients, if applicable
- •b. Urinalysis: protein (proteinuria) * +2 by dipstick method, or < 100 mg/dL by quantitative method and blood (hematuria) * +1 by dipstick method for normal renal function group patients
- •c. Hemoglobin * 9 g/dL
- •d. Absolute neutrophil count (ANC) * 1.5 x 109 /L
- •e. Platelet count * 100 x 109 /L
- •f. AST/SGOT and ALT/SGPT * 2.5 x ULN (or * 5 x ULN if transaminase elevation is due to disease involvement)
- •g. Serum total bilirubin * 1.5 ULN
- •h. Patient with normal renal function should have serum potassium, magnesium, phosphorus, total calcium (corrected for serum albumin) or ionized calcium within normal limits
- •5. Patient is able to swallow capsules
- •6. Patient, if sexually active (men and women of child bearing potential WOCBP), is agreeing to use double barrier method of contraception during the course of the study and for 3 months after completing study treatment. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months
- •7. Patient has signed a written informed consent prior to any screening procedures
排除标准
- •1. Patient has received prior treatment with DAC inhibitors including panobinostat
- •2. Patient is needing valproic acid for any medical condition including during the study or within 5 days prior to the first dose of panobinostat
- •3. Patient is taking any anti-cancer therapy concomitantly
- •4. Patient is requiring diuretics unless patient is taking potassium sparring diuretics
- •5. Patient has active CNS disease or brain metastasis, except those previously treated and stable for at least 3 months
- •6. Patient has 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. Patient has received:
- •a. prior chemotherapy * 3 weeks prior to start of treatment. Patient must have recovered from all therapy-related toxicities
- •b. biologic immunotherapy including monoclonal antibodies or experimental therapy * 4 weeks prior to start of study
- •c. radiation therapy * 4 weeks or limited field radiotherapy * 2 weeks prior to start of treatment
- •8.Patient has not recovered from all therapy-related toxicities to * grade 1 CTCAE or baseline
- •9. Patient has undergone major surgery * 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy to * grade 1 CTCAE or baseline
- •10. Patient has unresolved diarrhea * CTCAE grade 2
- •11. Patient has impaired cardiac function, including any one of the following:
- •a. LVEF < the lower limit of institutional norm, as determined by ECHO or MUGA
- •b. obligate use of a permanent cardiac pacemaker
- •c.congenital long QT syndrome
- •d. history or presence of ventricular tachyarrhythmias
- •e. resting bradycardia defined as < 50 beats per minute
- •f. QTcF > 450 msec on screening ECG
- •g. Complete left bundle branch block (LBBB), bifasicular 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). Patients
- •with stable atrial fibrillation are allowed in the study provided they do not meet the
- •other exclusion criteria
- •j. Myocardial infarction or unstable angina pectoris * 6 months prior to starting study
- •k. Congestive heart failure (New York Heart Association class III-IV)
- •l. Other clinically significant heart disease and vascular disease (e.g. uncontrolled
- •hypertension)
- •12. Patient is taking medications with relative risk of prolonging the QT interval or inducing
- •torsade de pointes, if such treatment cannot be discontinued or switched to a different
- •medication prior to starting study drug
- •13. Patient has acute renal failure (e.g., acute nephritis, nephritic syndrome, acute tubular
- •necrosis, glomerolunephritis, pyelonephritis, active hydronephrosis), history of renal
- •transplant, end stage renal disease (ESRD). However, ESRD is acceptable, if Group 4
- •(severe) patients are enrolled.
- •14. Patient is requiring dialysis
- •15. Patient has impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the absorption of panobinostat (e.g. ulcerative disease, uncontrolled
- •nausea, vomiting, diarrhea, mal-absorption syndrome, obstruction, or major stomach
- •and/or small bowel resection)
- •16. Patient has any other concurrent severe and
研究者
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