Back to resultsA Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Epoetin beta
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epoetin beta
Arm Description
Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram [IU/kg]) for 16 weeks.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Hemoglobin response rate index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02554942
Brief Title
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors
Official Title
An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epoetin beta
Arm Type
Experimental
Arm Description
Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram [IU/kg]) for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Epoetin beta
Other Intervention Name(s)
NeoRecormon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin response rate index
Time Frame
Up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Alcoy
ZIP/Postal Code
03804
Country
Spain
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Caceres
ZIP/Postal Code
10003
Country
Spain
City
El Palmar Murcia
ZIP/Postal Code
30120
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Manresa
ZIP/Postal Code
08243
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors
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