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

November 1, 2016 updated by: Hoffmann-La Roche

An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alcoy, Spain, 03804
      • Barakaldo, Spain, 48903
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08916
      • Caceres, Spain, 10003
      • El Palmar Murcia, Spain, 30120
      • La Laguna, Spain, 38320
      • Manresa, Spain, 08243
      • Salamanca, Spain, 37007
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
      • Zaragoza, Spain, 50009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epoetin beta
Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram [IU/kg]) for 16 weeks.
Drug: 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.
Other Names:
  • NeoRecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Up to 16 weeks
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin response rate index
Time Frame: Up to 16 weeks
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML17912

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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