Status:
COMPLETED
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cachexia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Key Inclusion criteria:
- Patients must sign an informed consent before assessment
- 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.
- Patients with stage IV NSCLC will be receiving or completed or discontinued standard chemotherapy or be chemotherapy-naive by choice.
- 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.
- 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.
- Body mass index (BMI) ≤ 30 kg/m2.
- Life expectancy of at least 4 months.
- Able to communicate well and comply with the requirements of the study, including by phone and written logs.
- Key Exclusion criteria:
- Patients who have received investigational anti-neoplastic therapy within 3 weeks of screening
- Evidence of inadequate organ or brain function, as defined by lab tests and imaging
- 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
- Pregnant or lactating women.
- 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
- Patients unwilling or unable to follow instructions.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01433263
Start Date
August 1 2011
End Date
April 1 2014
Last Update
March 2 2016
Active Locations (10)
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1
Novartis Investigative Site
Tucson, Arizona, United States, 85715
2
Novartis Investigative Site
Tampa, Florida, United States, 33647
3
Novartis Investigative Site
Chicago, Illinois, United States, 60611-3308
4
Novartis Investigative Site
Boston, Massachusetts, United States, 02114