CompletedPhase 2NCT01433263

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

Checked against the public recordLast updated Mar 2, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations10
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: BYM338 active drug; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Novartis Investigative SiteTucson, Arizona
  • Novartis Investigative SiteTampa, Florida
  • Novartis Investigative SiteChicago, Illinois
  • Novartis Investigative SiteBoston, Massachusetts
  • Novartis Investigative SiteCanton, Ohio
  • Novartis Investigative SiteSan Antonio, Texas
  • Novartis Investigative SiteVilnius
  • Novartis Investigative SiteBucharest
  • Novartis Investigative SiteSankt Gallen
  • Novartis Investigative SiteEdinburgh

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 2, 2016. Always confirm current availability with the study team.

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