- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599012
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
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:
- JiYoung Choi
- Phone Number: 82-2-3410-3660
- Email: jy210.choi@samsung.com
-
-
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.
Sponsor
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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