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

Not Recruiting

Trial ID: NCT01433263

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

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

A. Dimitrios Colevas, MD
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.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

Eligibility


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.

Intervention(s):

drug: BYM338 active drug

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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