Clinical Trial: Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Pancrea

Brief Summary: 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

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 [ Time Frame: 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.


Original Primary Outcome: Increase in thigh muscle volume as measured by MRI [ Time Frame: 8 Weeks ]

Current Secondary Outcome:

  • Percentage Change in Body Weight From Baseline at Week 7 and Week 9 [ Time Frame: Baseline, Week 7 and Week 9 ]
    Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 ]
    Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.
  • Time to Reach the Maximum Concentration After Drug Administration (Tmax) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 ]
    Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.
  • Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8 [ Time Frame: Baseline, Week 8 ]
    total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.
  • Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8 [ Time Frame: Baseline, Week 8 ]
    Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
  • Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7 [ Time Frame: Baseline, Week 4 and Week 7 ]
    Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
  • Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7 [ Time Frame: Baseline, Week 4 and Week 7 ]
    Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
  • Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7 [ Time Frame: Baseline, Week 4 and Week 7 ]
    Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
  • Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7 [ Time Frame: Baseline, Week 4 and Week 7 ]
    Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.


Original Secondary Outcome:

  • Measure: 6 minute walk test [ Time Frame: 8 Weeks ]
  • Measure: Efficacy in treating unintentional weight loss [ Time Frame: 8 weeks ]
  • Measure: Obtain pharmacokinetic data in this population [ Time Frame: 8 weeks ]
  • Measure: Efficacy in improving total lean body mass (LBM) and total bone mineral content [ Time Frame: 8 weeks ]
  • Measure: Improving physical activity and function [ Time Frame: 8 weeks ]


Information By: Novartis

Dates:
Date Received: August 24, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 2, 2016
Last Verified: February 2016