A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 17
- 主要终点
- Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
研究概览
简要总结
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Previously treated with oral bexarotene
Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
干预措施: Panobinostat (Drug)
No prior oral bexarotene treatment
Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
干预措施: Panobinostat (Drug)
结局指标
主要结局
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
时间窗: Baseline up to 6 Months of Follow up
Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.
次要结局
- The Overall Response Rate Using mSWAT Skin Score(Baseline up to Cycle 12, an average of 12 months)
- Time to Response for Responders(Baseline up to Cycle 12, an average of 12 months)
- Progression-free Survival (PFS)(Baseline up to Cycle 12, an average of 12 months)
- Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12(Baseline up to Cycle 12, an average of 12 months)
- Duration of Response (DOS)(Baseline up to Cycle 12, an average of 12 months)
- Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12(Baseline up to Cycle 12, an average of 12 months)
- Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12(Baseline up to Cycle 12, an average of 12 months)
- Maximum Plasma Concentration (Cmax) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Time to Peak Concentration (Tmax) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Time of Clast (Tlast) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Last Observed Plasma Concentration (Clast) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)