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

NCT ID: NCT02554942

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-09-30

Brief Summary

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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.

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 will receive weekly SC injection of epoetin beta (450 international units per kilogram \[IU/kg\]) for 16 weeks.

Group Type EXPERIMENTAL

Epoetin beta

Intervention Type DRUG

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.

Interventions

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Epoetin beta

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.

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
* 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
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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Alcoy, , Spain

Site Status

Barakaldo, , Spain

Site Status

Barcelona, , Spain

Site Status

Barcelona, , Spain

Site Status

Barcelona, , Spain

Site Status

Cáceres, , Spain

Site Status

El Palmar Murcia, , Spain

Site Status

Manresa, , Spain

Site Status

Salamanca, , Spain

Site Status

San Cristóbal de La Laguna, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ML17912

Identifier Type: -

Identifier Source: org_study_id