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

NCT ID: NCT02564094

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epoetin beta

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

Group Type EXPERIMENTAL

Epoetin beta

Intervention Type DRUG

Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.

Interventions

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Epoetin beta

Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.

Intervention Type DRUG

Other Intervention Names

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NeoRecormon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Plovdiv, , Bulgaria

Site Status

Plovdiv, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Stara Zagora, , Bulgaria

Site Status

Varna, , Bulgaria

Site Status

Varna, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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ML18043

Identifier Type: -

Identifier Source: org_study_id