NCT01433263已完成2 期
A Randomized, Double-blind, Placebo-controlled Multi-center Study of BYM338 for Treatment of Cachexia in Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
研究概览
简要总结
A safety & efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
30mg/kg BYM338
Experimental
干预措施: BYM338 active drug (Drug)
Placebo / late 30mg/kg BYM338
Placebo Comparator
干预措施: BYM338 active drug (Drug)
Placebo / late 30mg/kg BYM338
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
时间窗: Baseline, week 8
Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.
次要结局
- Percentage Change in Body Weight From Baseline at Week 7 and Week 9(Baseline, Week 7 and Week 9)
- Maximum Observed Serum Concentration (Cmax)(0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8)
- Time to Reach the Maximum Concentration After Drug Administration (Tmax)(0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8)
- Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8(Baseline, Week 8)
- Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8(Baseline, Week 8)
- Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7(Baseline, Week 4 and Week 7)
- Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7(Baseline, Week 4 and Week 7)
- Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7(Baseline, Week 4 and Week 7)
- Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7(Baseline, Week 4 and Week 7)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With CachexiaChronic Obstructive Pulmonary Disease (COPD) With CachexiaNCT01669174Novartis Pharmaceuticals67
已完成
2 期
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisNCT01423110Novartis Pharmaceuticals14
撤回
2 期
Study of Muscle Effects of BYM338 in Mechanically Ventilated PatientsMechanical VentilationNCT01868685Novartis Pharmaceuticals
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy ParticipantsHealthy VolunteersNCT04550195Bristol-Myers Squibb26
已完成
2 期
A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic AdultsSkeletal MuscleNCT01601600Novartis Pharmaceuticals40