CancerPhase 2NCT02599012
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
A Phase 2 study testing Ferinject® in people with Cancer and Anemia, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ferinject®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Sep 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Irwon-ro ,Kangnam-gu, 06351
JiYoung Choi, 82-2-3410-3660, jy210.choi@samsung.com
About this study
- 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.
- Being tested
- Ferinject®
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferinject®Drug
intravenous Ferinject 1000mg injection
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Experimental | Not described Receives: Drug: Ferinject® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Hemoglobin response
Measured: visit 4th after Ferinject injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start12 Sep 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ho Jang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599012
- Sponsor's protocol ID
- 2015-01-011-001
- Status last verified
- Feb 2017
- First submitted
- 7 Oct 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
Publications
Jang JH, Kim Y, Park S, Kim K, Kim SJ, Kim WS, Jung CW, Lee J, Lee SH. Efficacy of intravenous iron treatment for chemotherapy-induced anemia: A prospective Phase II pilot clinical trial in South Korea. PLoS Med. 2020 Jun 8;17(6):e1003091. doi: 10.1371/journal.pmed.1003091. eCollection 2020 Jun.
PubMed 32511251
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
- ClinicalTrials.gov ID
- NCT02599012
- Acronym / sponsor ID
- 2015-01-011-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2015 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Experimental | Drug: Ferinject® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferinject®intravenous Ferinject 1000mg injection | Drug | Subjects |
Primary outcome
Number of participants with Hemoglobin response
Time frame: visit 4th after Ferinject injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 32511251Jang JH, Kim Y, Park S, Kim K, Kim SJ, Kim WS, Jung CW, Lee J, Lee SH. Efficacy of intravenous iron treatment for chemotherapy-induced anemia: A prospective Phase II pilot clinical trial in South Korea. PLoS Med. 2020 Jun 8;17(6):e1003091. doi: 10.1371/journal.pmed.1003091. eCollection 2020 Jun.
- Iron deficient erythropoiesis might play key role in development of anemia in cancer patients.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferinject® in people with Cancer and Anemia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Hemoglobin response (time frame: visit 4th after Ferinject injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.