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



Status:Completed
Conditions:Lung Cancer, Other Indications
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2011
End Date:April 2014

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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


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.
We found this trial at
7
sites
Tampa, Florida 33613
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Boston, Massachusetts 02118
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Boston, MA
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Canton, Ohio 44718
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Chicago, Illinois 60612
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Tucson, Arizona 85745
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Tucson, AZ
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Vilnius,
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