A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors
- Registration Number
- NCT02554942
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Adults at least 18 years of age
- Presence of solid tumor(s)
- Receiving platinum-based therapy capable of inducing anemia
Exclusion Criteria
- Red blood cell transfusion within 7 days prior to study drug
- Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug
- Women who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epoetin beta Epoetin beta Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram \[IU/kg\]) for 16 weeks.
- Primary Outcome Measures
Name Time Method Incidence of adverse events Up to 16 weeks
- Secondary Outcome Measures
Name Time Method Hemoglobin response rate index Up to 16 weeks