NCT01065467已完成1 期
A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To obtain an early evaluation of efficacy by response rate using RECIST criteria.
研究概览
简要总结
The purpose of this research study is to determine the safety of LBH589 as well as to find out what side effects it may cause and how effective it is against melanoma. LBH589 is a drug which may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes, which are proteins normally produced by cells. These enzymes are known to play an important role in the development and reproduction of cancer cells. It is believed that LBH589 works by helping to promote the activity of enzymes which turn on the mechanisms in our cells that suppress cells from becoming cancerous.
详细描述
- Each treatment cycle lasts 28 days. During the cycles, participants will be taking LBH589 three days a week(Monday, Wednesday and Friday) every other week.
- During all treatment cycles participants will have a physical exam and will be asked general questions about their health and specific questions about any problems that they may be having. Participants will be seen at least weekly during the first cycle and then at least monthly while they remain on the study.
- Blood tests will be taken to check blood cell counts, how well their organs are functioning and to test for any infections. These blood samples will be obtained prior to the start of every cycle and at least weekly during the first cycle on this study.
- If the participant is a woman of child-bearing potential, she will be asked to undergo either a blood test or provide a urine specimen to check for pregnancy before starting cycle 1 and prior to the start of all subsequent cycles.
- As it is possible for LBH589 to affect the rhythm of the heart, EKGs will be checked frequently during participation on this study. These EKGs will be performed at the following time points: Cycle 1, day 1; Cycle 1, day 5; Cycle 1, Day 8; Cycle 1 day 15; and day 1 of each subsequent cycles.
- CT scans of the chest, abdomen and pelvis and an MRI of the brain will be performed after every 2 cycles or every 56 days.
- A second sample of the participant's tumor will be removed at the end of the first cycle on study.
- Participants will be in this research study for at least 2 months and may continue on the study of they are benefitting from the drug and are not experiencing any serious side effects.
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
- •Histologically or cytologically confirmed metastatic melanoma
- •Measurable disease
- •18 years of age or older
- •ECOG performance status of 0, 1 or 2
- •Normal organ and marrow function as outlined in the protocol
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatment and must be willing to use two methods of contraception during the study and for 3 months after last study drug administration
- •Clinically euthyroid
- •Biopsiable disease: Disease must be in the opinion of the treating investigator biopsiable such that there are minimal risks involved
排除标准
- •Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •May not be receiving any other study agents, anti-cancer therapy or radiation therapy
- •Known brain metastases or any history of brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to LBH589
- •Concomitant use of drugs with a risk of causing torsades de pointes
- •Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
- •Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
- •Impaired cardiac function
- •Uncontrolled hypertension
- •Patients with unresolved diarrhea grade 2 or greater
- •Impairment of the gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- •Pregnant or breastfeeding women
- •Individuals with a history of a different malignancy are ineligible except for the following circumstances: disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- •Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C
- •Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- •Uncontrolled and/or severe intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Treatment
Experimental
LBH589
干预措施: LBH589 (Drug)
结局指标
主要结局
To obtain an early evaluation of efficacy by response rate using RECIST criteria.
时间窗: 2 years
次要结局
- To estimate the disease control rate using RECIST criteria(2 years)
- Tp determine whether LBH589 effectively down regulates MITF in biopsy specimens of treated metastatic melanoma patients(2 years)
- To estimate time to disease progression.(3 years)
研究者
F. Stephen Hodi, MD
Melanoma Disease Center Director
Dana-Farber Cancer Institute
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung CancersRenal CancerNon Small Cell Lung Cancer (NSCLC)Soft Tissue SarcomaNCT01005797Medical University of South Carolina38
已完成
1 期
Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After CastrationProstate CancerProstatic NeoplasmsNCT00878436NYU Langone Health52
终止
2 期
Study of LBH589 (Panobinostat) to Treat Malignant Brain TumorsRecurrent Malignant GliomasNCT00848523Neurological Surgery, P.C.6
已完成
2 期
Efficacy and Safety Assessment of Oral LBH589 in Adult Patients With Advanced Soft TIssue Sarcoma After Pre-treatment FailureSoft Tissue SarcomaNCT01136499Centre Leon Berard53
已完成
1 期
Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic SyndromeAdvanced Myelodysplastic SyndromeAcute Myeloid LeukemiaNCT01463046University of California, San Francisco29