A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
| Sponsors |
Lead Sponsor: Hoffmann-La Roche |
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| Source | Hoffmann-La Roche | ||||||||||
| Brief Summary | This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals. |
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| Overall Status | Completed | ||||||||||
| Start Date | February 2005 | ||||||||||
| Completion Date | June 2006 | ||||||||||
| Primary Completion Date | June 2006 | ||||||||||
| Phase | Phase 4 | ||||||||||
| Study Type | Interventional | ||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 54 | ||||||||||
| Condition | |||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Epoetin beta Description: Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks. Arm Group Label: Epoetin beta Other Name: NeoRecormon |
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| Eligibility |
Criteria:
Inclusion Criteria: - Adults at least 18 years of age - Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer - Anemia with low erythropoeitin (EPO) levels Exclusion Criteria: - Poorly controlled hypertension - Relevant acute or chronic bleeding requiring therapy within 3 months before study drug - Treatment with EPO within the last 6 weeks - Pregnant or breastfeeding females Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
Bulgaria |
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| Verification Date |
November 2016 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||||||
| Condition Browse | |||||||||||
| Number Of Arms | 1 | ||||||||||
| Arm Group |
Label: Epoetin beta Type: Experimental Description: Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks. |
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| Study Design Info |
Allocation: Non-Randomized Intervention Model: Single Group Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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