Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01433263
First received: August 24, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Cachexia
Drug: BYM338 active drug
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Increase in thigh muscle volume as measured by MRI [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 minute walk test [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    scale

  • Efficacy in treating unintentional weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in weight

  • Obtain pharmacokinetic data in this population [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Efficacy in improving total lean body mass (LBM) and total bone mineral content [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in LBM and BMC

  • Improvement physical activity and function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in mobilty


Enrollment: 49
Study Start Date: August 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BYM338 active drug Drug: BYM338 active drug
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433263

Locations
United States, Arizona
Novartis Investigative Site
Tucson, Arizona, United States, 85715
United States, Florida
Novartis Investigative Site
Tampa, Florida, United States, 33647
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60611-3308
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02114
United States, Ohio
Novartis Investigative Site
Canton, Ohio, United States, 44718
United States, Texas
Novartis Investigative Site
San Antonio, Texas, United States, 78217
Lithuania
Novartis Investigative Site
Vilnius, Lithuania, LT 08661
Romania
Novartis Investigative Site
Bucharest, Romania, Sector 5
Switzerland
Novartis Investigative Site
St. Gallen, Switzerland, 9007
United Kingdom
Novartis Investigative Site
Edinburgh, United Kingdom, EH10 5HF
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceiticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01433263     History of Changes
Other Study ID Numbers: CBYM338X2202
Study First Received: August 24, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Wasting syndrome
emaciation
lung cancer
adenocarcinoma
pancreatic cancer

Additional relevant MeSH terms:
Cachexia
Body Weight
Body Weight Changes
Emaciation
Signs and Symptoms
Weight Loss

ClinicalTrials.gov processed this record on November 25, 2014