A Phase II, Multicentre Study of Oral LBH589 in Patients With Chronic Phase Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two Fusion Gene of the BCR and ABL Genes (BCR-ABL) Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Major (Complete/Partial) Cytogenetic Response (MCyR) Rate
研究概览
简要总结
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Panobinostat (LBH589)
Participants were administered panobinostat 20 milligram (mg) orally once a day (OD) three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat were administered at the same time each morning with 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
干预措施: LBH589 (Drug)
结局指标
主要结局
Major (Complete/Partial) Cytogenetic Response (MCyR) Rate
时间窗: From Start of the Study up to End of Study (approximately up to 19 Months)
The CyR, based on the percentage of Ph+ metaphases by karyotype analysis on a bone marrow aspirate, was ideally assessed from a minimum of 20 metaphases in each bone marrow sample. The CyR was defined as: major response including complete (CCyR; 0% Ph+ metaphases) or partial (PCyR; 1 to 35% Ph+ metaphases), minor (36 to 65% Ph+ metaphases), minimal (66 to 95% Ph+ metaphases) or none (96 to 100% Ph+ metaphases).
次要结局
- Area Under the Plasma Concentration (AUC0-24) of Panobinostat(Pre-dose, and 0.25, 1-2, 3-4, 24, and 48 hours post-dose on Day 1)
- Duration of Major (Complete/Partial) Cytogenetic Response (MCyR) Rate(From Start of the Study up to End of Study (approximately up to 19 Months))
- Complete Hematologic Response (CHR) Rate(From Start of the Study up to End of Study (approximately up to 19 Months))
- Complete Cytogenetic Response (CCyR) and Overall (Complete/Partial/Minor/Minimal) Cytogenetic Response (OCyR) Rates(From Start of the Study up to End of Study (approximately up to 19 Months))
- Major (MMR) and Complete (CMR) Molecular Response Rates(From Start of the Study up to End of Study (approximately up to 19 Months))
- BCR-ABL Mutations of Participants at Study Entry and, in Responding Participants and at the Time of Disease Progression(From Start of the Study up to End of Study (approximately up to 19 Months))
- Time to Peak Concentration (Tmax) of Panobinostat(Pre-dose, and 0.25, 1-2, 3-4, 24, and 48 hours post-dose on Day 1)
- Progression Free Survival Time(From Start of the Study up to End of Study (approximately up to 19 Months))
- Maximum Plasma Concentration (Cmax) of Panobinostat(Pre-dose, and 0.25, 1-2, 3-4, 24, and 48 hours post-dose on Day 1)
- Last Observed Plasma Concentration (Clast) of Panobinostat(Pre-dose, and 0.25, 1-2, 3-4, 24, and 48 hours post-dose on Day 1)
- Time of Clast (Tlast) of Panobinostat(Pre-dose, and 0.25, 1-2, 3-4, 24, and 48 hours post-dose on Day 1)
- QT Interval (QTc) in Participants Receiving Oral Panobinostat at Baseline and Change From Baseline to Extreme Value(From Start of the Study up to End of Study (approximately up to 19 Months))
- Safety and Tolerability Profile of Oral Panobinostat(From Start of the Study up to 28 Days After the last dose of Study Drug (approximately up to 19 Months))