Back to resultsA Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Bulgaria
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epoetin beta
Arm Description
Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
Outcomes
Primary Outcome Measures
Response rate according to hemoglobin level
Transfusion requirement rate
Predictive value of reticulocyte increase
Secondary Outcome Measures
Incidence of adverse events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02564094
Brief Title
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
Official Title
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (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 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.
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
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epoetin beta
Arm Type
Experimental
Arm Description
Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Epoetin beta
Other Intervention Name(s)
NeoRecormon
Intervention Description
Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.
Primary Outcome Measure Information:
Title
Response rate according to hemoglobin level
Time Frame
At Week 4
Title
Transfusion requirement rate
Time Frame
From Weeks 5 to 12
Title
Predictive value of reticulocyte increase
Time Frame
At Week 2
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to approximately 6 months
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
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
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
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1757
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
8000
Country
Bulgaria
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
We'll reach out to this number within 24 hrs