Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
NCT ID: NCT01433263
Last Updated: 2016-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2011-08-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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30mg/kg BYM338
BYM338 active drug
Placebo / late 30mg/kg BYM338
BYM338 active drug
Placebo
Interventions
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BYM338 active drug
Placebo
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Canton, Ohio, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Vilnius, , Lithuania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Sankt Gallen, , Switzerland
Novartis Investigative Site
Edinburgh, , United Kingdom
Countries
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References
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Epstein SA, Doles JD, Dasgupta A. KLF10: a point of convergence in cancer cachexia. Curr Opin Support Palliat Care. 2024 Sep 1;18(3):120-125. doi: 10.1097/SPC.0000000000000711. Epub 2024 Jul 15.
Other Identifiers
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CBYM338X2202
Identifier Type: -
Identifier Source: org_study_id
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