A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly

Sponsors

Lead Sponsor: Hoffmann-La Roche

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 February 2005
Completion Date June 2006
Primary Completion Date June 2006
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: Epoetin beta

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

Bulgaria

Verification Date

November 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Epoetin beta

Type: Experimental

Description: Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov