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

Brief Summary

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 Pancreas”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2014

Interventions Used in this Clinical Trial

  • Drug: BYM338 active drug
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: BYM338 active drug
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
    • Time Frame: week 8
      Safety Issue?: No

Secondary Measures

  • Percentage Change in Body Weight From Baseline at Week 7 and Week 9
    • Time Frame: Week 7 and Week 9
      Safety Issue?: No
  • Maximum Observed Serum Concentration (Cmax)
    • Time Frame: Day 1 and Week 8
      Safety Issue?: No
  • Time to Reach the Maximum Concentration After Drug Administration (Tmax)
    • Time Frame: Day 1 and Week 8
      Safety Issue?: No
  • 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: Week 8
      Safety Issue?: No
  • Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8
    • Time Frame: Week 8
      Safety Issue?: No
  • 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: Week 4 and Week 7
      Safety Issue?: No
  • 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: Week 4 and Week 7
      Safety Issue?: No
  • Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7
    • Time Frame: Week 4 and Week 7
      Safety Issue?: No
  • Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7
    • Time Frame: Week 4 and Week 7
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Key Inclusion criteria:

1. Patients must sign an informed consent before assessment

2. Patients with pathologically and/or clinically confirmed diagnosis of stage IV non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV adenocarcinoma of the pancreas.

3. Patients with stage IV NSCLC will be receiving or completed or discontinued standard chemotherapy or be chemotherapy-naive by choice.

4. Patients with stage III/IV pancreatic adenocarcinoma will be receiving standard chemotherapy or no chemotherapy. If patients are receiving chemotherapy, a change in chemotherapy is not expected.

5. Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation. Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2 week period.

6. Body mass index (BMI) ≤ 30 kg/m2.

7. Life expectancy of at least 4 months.

8. Able to communicate well and comply with the requirements of the study, including by phone and written logs.

Key Exclusion criteria:

1. Patients who have received investigational anti-neoplastic therapy within 3 weeks of screening

2. Evidence of inadequate organ or brain function, as defined by lab tests and imaging

3. Patients with severe and/or uncontrolled medical conditions that could interfere with the study (e.g. heart conditions, high blood pressure, diabetes, infection) uncontrolled pain or any other non-stable illness

4. Pregnant or lactating women.

5. Women capable of becoming pregnant must use highly effective contraception during the study and for 8 weeks after stopping treatment. All female patients must have negative pregnancy test results throughout the study

6. Patients unwilling or unable to follow instructions.

Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceiticals, Study Director, Novartis Pharmaceuticals

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01433263