Anemia Treatment for Advanced NSCLC Patients Receiving Chemotherapy
Tracking InformationStart Date ICMJE | June 2009 |
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Estimated Primary Completion Date | February 2017 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: March 5, 2009) | Overall survival (OS) [ Time Frame: from randomization until death or end of study ] [ Designated as safety issue: Yes ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00858364 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: March 5, 2009) | - Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ] [ Designated as safety issue: Yes ]
- Incidence of at least 1 RBC transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment period [ Time Frame: Study day 29 to end of efficacy treatment period ] [ Designated as safety issue: No ]
- Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with RBC transfusions [ Time Frame: Randomization to 30 days after last dose of darbepoetin alfa ] [ Designated as safety issue: Yes ]
- Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ] [ Designated as safety issue: Yes ]
- Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ] [ Designated as safety issue: Yes ]
- Incidence of at least 1 RBC transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of treatment period [ Time Frame: study day 1 until end of efficacy treatment period ] [ Designated as safety issue: No ]
- Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | Anemia Treatment for Advanced NSCLC Patients Receiving Chemotherapy |
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Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy |
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Brief Summary | 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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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | - Non-small Cell Lung Cancer
- Anemia
- Cancer
- Lung Cancer
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Intervention ICMJE | |
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Study Arms / Comparison Groups | - A: Active Comparator
darbepoetin alfa 500 µg (Q3W) Intervention: Drug: darbepoetin alfa 500 mcg Q3W - B: Placebo Comparator
Placebo Q3W Intervention: Drug: placebo
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Recruitment InformationEstimated Enrollment ICMJE | 3000 |
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Estimated Completion Date | June 2019 |
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Estimated Primary Completion Date | February 2017 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | 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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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Amgen Call Center | 866-572-6436 | | |
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Location Countries ICMJE | United States, Austria, Belgium, Canada, Chile, Czech Republic, Greece, Hong Kong, India, Ireland, Italy, Luxembourg, Mexico, Netherlands, Philippines, Poland, Russian Federation, Spain, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00858364 |
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Responsible Party | Global Development Leader, Amgen Inc. |
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Study ID Numbers ICMJE | 20070782 |
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Study Sponsor ICMJE | Amgen |
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Collaborators ICMJE | |
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Investigators ICMJE | |
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Information Provided By | Amgen |
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