Anemia Treatment for Advanced NSCLC Patients Receiving Chemotherapy - NCT00858364- (Clinical Trial 276784)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy276784.aspx
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| City: |
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Oshkosh |
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State:
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WI |
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| Conditions: |
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Non-small Cell Lung Cancer - Anemia - Cancer - Lung Cancer |
| Purpose: |
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This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in
subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the
treatment of metastatic (stage IV) or advanced stage IIIB with malignant pleural effusion
NSCLC. Approximately 3000 subjects with metastatic (stage IV) or advanced stage IIIB with
malignant pleural effusion NSCLC receiving or about to receive first line chemotherapy will
be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A:
darbepoetin alfa 500 µg Q3W, Group B: placebo Q3W)
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subjects with metastatic (stage IV) or advanced stage IIIB with malignant pleural
effusion NSCLC
- Receiving or about to receive first line cyclic chemotherapy for NSCLC and expected
to receive at least 2 additional cycles of cyclic chemotherapy
- Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed at
screening
- 18 years of age or older at screening
- Life expectancy > 6 months based on the judgment of the investigator and documented
at screening
- Subjects with chemotherapy-induced anemia as defined as having a hemoglobin level
less than or equal to 11.0 g/dL at screening
Exclusion Criteria:
- Known primary benign or malignant hematologic disorder which can cause anemia
- History of, or current active cancer other than NSCLC, with the exception of
curatively resected non-melanomatous skin cancer, curatively treated cervical
carcinoma in situ, or other primary solid tumors curatively treated with no known
active disease present and no curative treatment administered for the last 3 years
- Subjects with a history of brain metastasis
- Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as
determined by the investigator at screening
- History of neutralizing antibody activity to rHuEPO or darbepoetin alfa
- Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia
as determined by the investigator at screening. Subjects with known myocardial
infarction within 6 months prior to screening
- Subjects with a history of seizure disorder taking anti-seizure medication within 30
days of screening
- Clinically significant systemic infection or uncontrolled chronic inflammatory
disease (eg, rheumatoid arthritis, inflammatory bowel disease) at the time of
screening as determined by the investigator
- Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface
antigen, or seropositive for hepatitis C virus
- History of pure red cell aplasia
- History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6
months prior to screening
- Received any RBC transfusion within 28 days prior to randomization.
- Plan to receive any RBC transfusion between randomization and study day 1
- Known previous treatment failure to ESAs (ie, rHuEPO, darbepoetin alfa)
- ESA therapy within the 28 days prior to screening
- Known hypersensitivity to recombinant ESAs or the excipients contained within the
investigational product |
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| Study is available at: |
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Research Site
Oshkosh, WI
United States
Primary Contact:
Amgen Call Center
Phone: 866-572-6436 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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