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
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San Antonio |
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Texas |
| Zip Code: |
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78217 |
| Conditions: |
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Cachexia |
| Purpose: |
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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
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT01433263 |
| Primary Contact: |
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Study Director
Novartis Pharmaceiticals
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Phone: +1 862-778-8300
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| Backup Contact: |
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N/A |
| Location Contact: |
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San Antonio, Texas 78217
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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