NCT01056601终止2 期
Phase II Study of Panobinostat (LBH589) Given in Combination With Bortezomib (Velcade) in Patients With Pancreatic Cancer Progressing on Gemcitabine Therapy Alone or Gemcitabine in Combination
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer cells but the mechanism is not well defined but has been determined to be cytostatic. Combining these two drugs may work together in the treatment of pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of locally advanced or metastatic pancreatic cancer (except neuroendocrine tumors, but including ampullary cancer) with progression after standard first line therapy that included gemcitabine (single agent or combination)
- •Measurable disease on computated tomography (CT) scan per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •At least 28 days from previous systemic therapy, including investigational agents and 1st dose of study treatment and recovered from any acute toxic effects of that treatment before study enrollment.
- •Has Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 - Ability to provide written consent
- •Must meet hematology and biochemistry laboratory criteria within 14 days of study enrollment:
- •Neutrophil count >1500/mm^3
- •Platelet count >100,000/mm^L
- •Hemoglobin > or = 9 g/dL
- •Aspartate aminotransferase (AST/SGOT) or Alanine transaminase (ALT/SGPT) < or = 2.5 times upper limit of normal (ULN)or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement
- •Serum bilirubin < or = 1.5 x ULN
- •Serum creatinine < or = 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
- •Total serum calcium (corrected for serum albumin) or ionized calcium ≥ lower limit of normal (LLN)
- •Serum phosphorus > or = LLN
- •Serum potassium > or = LLN
- •Serum sodium ≥ LLN
- •Serum magnesium ≥ LLN
- •Serum albumin ≥ LLN or 3g/dl
- •Patients with any elevated Alkaline Phosphatase due to bone metastasis can be enrolled
- •Baseline multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must demonstration left ventricular ejection fraction (LVEF) > or = 50%
- •Normal thyroid function within normal limits. Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy tests within 7 days of study treatment administration and willing to use 2 methods of contraception
排除标准
- •> 1 prior systemic treatment regimen for pancreatic cancer
- •Prior histone deacetylase (HDAC), deacetylase (DAC), heat shock protein 90 (HSP90) inhibitors or valproic acid for treatment of cancer
- •Anyone needing valproic acid for any medical condition during the study or 5 days prior to panobinostat treatment
- •Impaired cardiac function
- •Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute), QTcF > 450 msec on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
- •Presence of atrial fibrillation (ventricular heart rate >100 bpm)
- •Previous history angina pectoris or acute myocardial infarction (MI) within 6 months of study enrollment
- •Congestive heart failure (New York Heart Association functional classification III-IV) or baseline MUGA/Echo shows LVEF < 50%
- •Uncontrolled hypertension defined as hypertensive blood pressure of SBP > 140 or DBP > 90, despite antihypertensive medications
- •History of deep vein thrombosis (DVT), pulmonary emboli or other blood clotting abnormality within 3 months of study enrollment
- •Ongoing need for anti-coagulation therapy except daily low dose aspirin (≤ 100 mg/day) or low molecular weight heparin
- •Concomitant use of drugs with risk of causing torsades de pointes
- •Anyone with unresolved diarrhea > or = grade 2 at time of enrollment
- •Impairment of gastrointestinal function or disease that may significantly alter the absorption of panobinostat
- •Grade 2 or greater peripheral neuropathy within 14 days of enrollment
- •Serious concomitant medical or psychiatric disorders (e.g., active infection, uncontrolled diabetes)
- •Patients who have received chemotherapy, any investigational agent or undergone major surgery < 4 weeks prior to starting study drug
- •Male patients whose sexual partners are WOCBP and not using double method of contraception during the study and 3 months following.
- •Known positivity for human immunodeficiency virus (HIV) or hepatitis C
- •Hypersensitivity to bortezomib, boron or mannitol History of another primary malignancy within 5 years other than curatively treated CIS of the cervix, or basal or squamous cell carcinoma of the skin
研究组 & 干预措施
Pancreatic Cancer Patients
Experimental
Pancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.
干预措施: Bortezomib (Drug)
Pancreatic Cancer Patients
Experimental
Pancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.
干预措施: Panobinostat (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Up to 1 Year
Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
次要结局
- Number of Participants by Tumor Response(Up to 1 Year)
- Duration of Response(Up to 1 Year)
研究者
研究点 (1)
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