Blood and Lymph Conditions

All Conditions

Anemia

Hematologic Diseases

Micronutrients

All Drugs and Chemicals

Hematinics

Mineral

Iron

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

Intravenous bolus injection given over app. 2 minutes only once

Monofer(R)

The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.

Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA).

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Epoetin Alfa

Peginesatide starting dose of 0.1 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 3 weeks (Q3W) for a total of 4 doses.

Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses.

Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses.

Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses.

peginesatide

Affymax

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.

This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.

Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia	NCT01280240	Patients With C...	Monofer(R)	18 Years -	Pharmacosmos A/S
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia	NCT01280240	Patients With C...	Monofer(R)	18 Years -	Pharmacosmos A/S
Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy	NCT00272662	Chemotherapy In... Cancer	peginesatide	18 Years - 80 Years	Affymax
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia	NCT01280240	Patients With C...	Monofer(R)	18 Years -	Pharmacosmos A/S
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 cia

Every month we try and update this database with for cia 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 cia

Every month we try and update this database with for cia 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 cia 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.