A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors
An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia
1 other identifier
interventional
28
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2004
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedNovember 2, 2016
November 1, 2016
1.3 years
September 17, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
Up to 16 weeks
Secondary Outcomes (1)
Hemoglobin response rate index
Up to 16 weeks
Study Arms (1)
Epoetin beta
EXPERIMENTALParticipants will receive weekly SC injection of epoetin beta (450 international units per kilogram \[IU/kg\]) for 16 weeks.
Interventions
Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks.
Eligibility Criteria
You may qualify if:
- Adults at least 18 years of age
- Presence of solid tumor(s)
- Receiving platinum-based therapy capable of inducing anemia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Alcoy, 03804, Spain
Unknown Facility
Barakaldo, 48903, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Barcelona, 08041, Spain
Unknown Facility
Barcelona, 08916, Spain
Unknown Facility
Cáceres, 10003, Spain
Unknown Facility
El Palmar Murcia, 30120, Spain
Unknown Facility
Manresa, 08243, Spain
Unknown Facility
Salamanca, 37007, Spain
Unknown Facility
San Cristóbal de La Laguna, 38320, Spain
Unknown Facility
Valencia, 46010, Spain
Unknown Facility
Valencia, 46026, Spain
Unknown Facility
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 18, 2015
Study Start
June 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
November 2, 2016
Record last verified: 2016-11