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

Phase 2

• Conditions: Anemia; Cancer
• Interventions: Drug: Ferinject®

• Registration Number: NCT02599012
• Lead Sponsor: Samsung Medical Center

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-12
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	Ferinject®	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Hemoglobin response	visit 4th after Ferinject injection

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Irwon-ro ,Kangnam-gu, Korea, Republic of