Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Adenocarcinoma

Postoperative Complications

Anemia

Hematologic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Micronutrients

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Iron

Hepcidins

All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Intravenous ferric carboxymaltose

Austin G Acheson, MD FRCS

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).

It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Intravenous Iron: Measuring Response in Anemic Surgical Patients

An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron

To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit

To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase

To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients

To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy

To monitor changes in C Reactive Protein levels over the course of the study, and review if this can predict response to intravenous iron therapy, or is associated with changes in hepcidin

Nottingham University Hospitals NHS Trust

Mineral

Iron isomaltoside 1000

Trace Elements

Iron Supplement

Iron isomaltoside intravenously as bolus or infusion

intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

iron isomaltoside 1000

oral, 200 mg per day (100 mg bid),12 weeks

iron sulphate

Lars Lykke Thomsen, MD

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Pharmacosmos A/S

The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

Iron Isomaltoside 1000

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Iron Sulphate

Total

Age, Categorical

Sex: Female, Male

India

Germany

Denmark

Spain

Poland

Russian Federation

Sweden

United States

Region of Enrollment

Vice President Research & Development Department

The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.

Change in Hb Concentration

Change in Hemoglobin From Baseline to Week 24

Overall Study

Nutritional and Metabolic Diseases

Immune System Diseases

Anemia, Iron-Deficiency

Iron Deficiencies

Lymphoproliferative Disorders

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 4 (week 2).

Subjects will be treated according to the local institutional practice.

Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.

Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2).

Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.

Ferric carboxymaltose

Torbjörn Karlsson, MD, PhD

Morgan McNamara

Anaemia and functional iron deficiency are common conditions in patients with lymphoid malignancies, conditions which reduce significantly the quality of life and increase morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but recently their use has been shown to have a negative impact on overall survival in different oncology populations. Recently published data suggest that intravenous (IV) iron can be effective in anaemia treatment, even without ESAs. This exploratory study is the first clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the data generated may be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in subjects suffering from lymphoid malignancies.

Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of FCM in the treatment of anaemia in LPD subjects with functional iron deficiency (FID), undergoing chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion to receive intravenous (IV) infusions of FCM or no FCM infusions (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). After randomisation, the visits are scheduled weekly until Week 8.

Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy

Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional Iron Deficiency Receiving Chemotherapy

Vifor Pharma

A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Ferrous Sulphate

Austin G Acheson, MBBS MD FRCS

116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).

It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.

At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.

The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05).

Randomization will be performed independently to the trial team using a computer generated variable block randomization program.

All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy

To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.

Hematinic markers include ferritin, iron, transferrin, transferrin saturation, erythropoietin.

To review the use of hepcidin as a biomarker to predict response to therapy.

Iron transport proteins include DMT TFR1, Ferroportin, Ferritin. As acquired from examination of pathology tissue specimen excised.

Post-operative outcomes include morbidity, mortality, length of stay.

Quality of Life questionnaires will be used (SF-36\[short form 36\] and EQ-5D)

National Institute for Health Research, United Kingdom

Heart and Blood Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Chronic Disease

Lymphoma

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Pharmaceutical Solutions

NOX-H94

Placebo solution

Kai Riecke, MD

This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in patients with anemia of chronic disease (ACD). Furthermore, this study is intended to provide data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to choose the appropriate dose and dose schedule of subsequent efficacy studies.

Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in iron concentrations in the blood and subsequently impair formation of red blood cells. Treatment with NOX-H94 is expected to inhibit this patho-mechanism by binding and inactivating hepcidin.

Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer

Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer

• Hb increase ≥1 g/dL OR reticulocyte index normalization (≥1%) at any time point until 1 week after the end of treatment

AND absence of all of the following treatment failure criteria until 1 week after the end of treatment:

* Erythrocyte transfusion, ESA or IV iron,
* Hb drop by ≥1 g/dL
* Treatment interruption due to adverse events (AEs)

Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint

Proportion of treatment failures at study visits V4, V6, V8, and V10, as defined for the primary efficacy endpoint

Adverse events, Safety signals derived from laboratory diagnostics, vital signs.

Absolute concentrations and change from baseline

TME Pharma AG

Syndrome

Iron Overload

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Deferasirox

Chelating Agents

Iron Chelating Agents

evaluating the effect of -Exjade (Deferasirox)_on oxidative stress parameters of blood cells in patients with Low risk Mylodysplastic syndrome ( MDS) with Iron over load

Exjade

Rachmilewitz Eliezer, MD

Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.

Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load

A Phase IV , Multicenter ,Open Label ,Non Comparative ,Investigator Initiated Study , Evaluating the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load

Hadassah Medical Organization

Tel-Aviv Sourasky Medical Center

Sheba Medical Center

Soroka University Medical Center

Wolfson Medical Center

Head of Hematology Department , E. Wolfson Medical center ,Holon- Israel.

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Immunoproliferative Disorders

Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 3 (week 2).

Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.

Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 3 (Week 2).

Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.

Katodritou Eirini, MD

Timothy R Cushway

Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of ferric carboxymaltose (FCM) in treatment of anaemia in subjects with multiple myeloma (MM) initiating chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion and randomised to receive intravenous infusions of FCM or standard care (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). Thereafter the visits are scheduled at Weeks 0, 2, 4, 6 and 8.

Patients will be randomised into two groups. One will receive active FCM treatment and the other group will receive local standard of care.

Active treatment group: Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the first scheduled chemotherapy cycle or within 24 hours before or after receiving chemotherapy. In subjects of weight ≤66 kg, the first dose (500 mg) will be administered on the day of the first scheduled chemotherapy cycle and the second dose (500 mg) on the next study visit.

Standard of care group: Subjects will be treated according to the local institutional practice if requiring management of symptomatic anaemia. Intravenous iron should only be used to treat absolute iron deficiency (as defined as ferritin less than the lower limit of normal based on the test reference ranges). Patients with absolute iron deficiency are not eligible for inclusion to the study.

Rescue medication to manage anaemia is permitted in both arms at the discretion of the treating physician and/or per institutional practice.

Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy

Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Multiple Myeloma & Iron Restricted Erythropoiesis Receiving Chemotherapy

Mean change in Hb from baseline to Weeks 4, 6 and 8 (end of treatment) in the absence of any red cell transfusion or erythropoiesis stimulating agents (ESA) treatment.

Percentage of subjects with blood Hb response of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment.

Percentage of subjects with a blood Hb correction to at least 12 g/dL in the absence of any red cell transfusion or ESA treatment

Median time to Hb response defined as increase in Hb equal to or more than 1 g/dL in the absence of any red cell transfusion or ESA treatment

Proportion of subjects receiving red blood cell transfusions or subjects treated with ESA during the study period

Adverse events: type, nature, incidence and outcome

Mean change in serum ferritin from baseline to Weeks 2, 4, 6 and 8

Mean change in TSAT from baseline to Weeks 2, 4, 6 and 8

Mean change in serum iron from baseline to Weeks 2, 4, 6 and 8

Mean change in endogenous erythropoietin from baseline to Weeks 2, 4, 6 and 8

Mean change in blood reticulocyte haemoglobin content/red blood cell size factor from baseline to Weeks 2, 4, 6 and 8

Mean change in percentage of hypochromic red cells/percentage of low Hb density from baseline to Weeks 2, 4, 6 and 8

Mean change in hepcidin from baseline to Weeks 2, 4, 6 and 8

Mean change in interleukin-6 from baseline to Weeks 2, 4, 6 and 8

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S
Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy	NCT01101399	Iron-Deficiency...	Ferric carboxym...	18 Years -	Vifor Pharma
Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy	NCT01101399	Iron-Deficiency...	Ferric carboxym...	18 Years -	Vifor Pharma
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia	NCT01701310	Anemia Colorectal Neop...	Ferric carboxym... Ferrous Sulphat...	18 Years -	Nottingham University Hospitals NHS Trust
Intravenous Iron: Measuring Response in Anemic Surgical Patients	NCT02057471	Colorectal Neop... Anemia	Intravenous fer...	18 Years -	Nottingham University Hospitals NHS Trust
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer	NCT01691040	Anemia of Chron...	NOX-H94 Placebo solutio...	18 Years -	TME Pharma AG
Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load	NCT00452660	Myelodysplastic...	Exjade	18 Years -	Wolfson Medical Center
Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy	NCT01100879	Iron-Deficiency...	Ferric carboxym...	18 Years -	Vifor Pharma
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer	NCT01691040	Anemia of Chron...	NOX-H94 Placebo solutio...	18 Years -	TME Pharma AG
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S

Spots Global Cancer Trial Database for iron

Every month we try and update this database with for iron cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iron

Every month we try and update this database with for iron cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iron cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.