Clinical trialPhase 2Completed
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2011
- Expected end
- April 2014
- Enrollment
- 57 participants
- Sites
- 10
- Primary outcomes
- Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
- Sponsor
- Industry
- Results posted
- 2015-05-13
- Last update
- 2 March 2016
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Brief summary public domain (ClinicalTrials.gov)
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
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 [Baseline, week 8]. Mean, Percentage Change of TMV (Standard Deviation). 30mg/kg BYM338 (n=15): 2.0 (8.094); Placebo / Late 30mg/kg BYM338 (n=22): 0.65 (8.239).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage Change in Body Weight From Baseline at Week 7 and Week 9 [Baseline, Week 7 and Week 9]. Mean, Percent Change of Weight (kg) (Standard Deviation). Week 7 (n= 15, 17): 30mg/kg BYM338 (n=29): -3.3 (5.035); Placebo / Late 30mg/kg BYM338 (n=28): -0.68 (4.457). Week 9 (n=14,16): 30mg/kg BYM338 (n=29): -1.8 (7.131); Placebo / Late 30mg/kg BYM338 (n=28): -0.32 (3.271).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, ng/ml (Standard Deviation). 30mg/kg BYM338 (n=29): 422 (142); Placebo / Late 30mg/kg BYM338 (n=14): 408 (78.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Median, hr (Inter-Quartile Range). 30mg/kg BYM338 (n=29): 2.05 (1.83 to 3.92); Placebo / Late 30mg/kg BYM338 (n=14): 2.22 (2.00 to 4.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, Percentage Change in LBM (Standard Deviation). 30mg/kg BYM338 (n=19): 4.97 (7.537); Placebo / Late 30mg/kg BYM338 (n=22): 2.41 (4.625).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, Percentage Change in BMD (Standard Deviation). 30mg/kg BYM338 (n=19): 0.51 (3.712); Placebo / Late 30mg/kg BYM338 (n=22): 0.14 (4.14).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, percentage change in number of steps (Standard Deviation). Week 4 (n=18, 23): 30mg/kg BYM338 (n=27): 917.78 (3720.491); Placebo / Late 30mg/kg BYM338 (n=28): 63.59 (130.913). Week 7 (n=13, 22): 30mg/kg BYM338 (n=27): -17.37 (80.350); Placebo / Late 30mg/kg BYM338 (n=28): 35.80 (119.486).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, percentage change in time (minutes) (Standard Deviation). Week 4 (n=18, 23): 30mg/kg BYM338 (n=27): -0.05 (10.049); Placebo / Late 30mg/kg BYM338 (n=28): 52.25 (207.403). Week 7 (n=13, 22): 30mg/kg BYM338 (n=27): 107.85 (280.791); Placebo / Late 30mg/kg BYM338 (n=28): 60.25 (222.366).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, percentage change in time (minutes) (Standard Deviation). Week 4 (n=18, 23): 30mg/kg BYM338 (n=27): 1.82 (78.364); Placebo / Late 30mg/kg BYM338 (n=28): 38.17 (111.361). Week 7 (n=13, 22): 30mg/kg BYM338 (n=27): 41.90 (251.291); Placebo / Late 30mg/kg BYM338 (n=28): 23.76 (99.268).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
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]. Mean, percentage change in time (minutes) (Standard Deviation). Week 4 (n=18, 22): 30mg/kg BYM338 (n=27): 1446.69 (6011.324); Placebo / Late 30mg/kg BYM338 (n=28): 85.30 (159.949). Week 7 (n=13, 21): 30mg/kg BYM338 (n=27): -31.64 (67.180); Placebo / Late 30mg/kg BYM338 (n=28): 33.39 (129.218).