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Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Trial ID: NCT01433263
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
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
Winston Chen and Phyllis Huang Professor
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Clinical Professor, Medicine - Oncology
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
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
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.
drug: BYM338 active drug
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office