The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients

February 7, 2017 updated by: Jun Ho Jang, Samsung Medical Center
  • Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
  • Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
  • Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
  • In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

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

    • Irwon-ro ,Kangnam-gu
      • Seoul, Irwon-ro ,Kangnam-gu, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who diagnosed with solid cancer or lymphoma
  • Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment

    • anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"
  • Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment

Exclusion Criteria:

  • Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment
  • Subjects with uncontrolled infection
  • Subjects with ongoing bleeding
  • Deteriorated organ function
  • poor performance state (ECOG 3-4)
  • Subjects whose disease involves bone marrow
  • Ferritin > 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Subjects
intravenous Ferinject 1000mg injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Hemoglobin response
Time Frame: visit 4th after Ferinject injection
visit 4th after Ferinject injection

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (ACTUAL)

September 12, 2015

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (ESTIMATE)

November 6, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-01-011-001

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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