Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
Sponsors
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.
Overall Status
Completed
Start Date
2005-02-01
Completion Date
2006-06-01
Primary Completion Date
2006-06-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Response rate according to hemoglobin level |
At Week 4 |
|
Transfusion requirement rate |
From Weeks 5 to 12 |
|
Predictive value of reticulocyte increase |
At Week 2 |
Secondary Outcome
Measure |
Time Frame |
|
Incidence of adverse events (AEs) |
Up to approximately 6 months |
Enrollment
54
Condition
Intervention
Intervention Type
Drug
Intervention Name
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
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
Overall Official
Last Name |
Role |
Affiliation |
|
Clinical Trials |
Study Chair |
Hoffmann-La Roche |
Location
Facility |
|
Plovdiv 4000 Bulgaria |
|
Plovdiv 4004 Bulgaria |
|
Sofia 1527 Bulgaria |
|
Sofia 1756 Bulgaria |
|
Sofia 1757 Bulgaria |
|
Sofia 1784 Bulgaria |
|
Stara Zagora 8000 Bulgaria |
|
Varna 9002 Bulgaria |
|
Varna 9010 Bulgaria |
Location Countries
Country
Bulgaria
Verification Date
2016-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Epoetin Alfa
Arm Group
Arm Group Label
Epoetin beta
Arm Group Type
Experimental
Description
Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
September 28, 2015
Study First Submitted Qc
September 28, 2015
Study First Posted
September 30, 2015
Last Update Submitted
November 1, 2016
Last Update Submitted Qc
November 1, 2016
Last Update Posted
November 2, 2016
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.