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

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01433263
First received: August 24, 2011
Last updated: March 12, 2014
Last verified: March 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


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: April 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433263

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 19 Study Locations
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: March 12, 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:
Adenocarcinoma
Cachexia
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014