Completed PHASE1 INTERVENTIONAL 2-arm NCT01213979

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA) (PK-CIA-04)

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)(PK-CIA-04)

Sponsor: Pharmacosmos A/S

Conditions Non-hematological Malignancies

Interventions 1000 mg iron isomaltoside 1000 500 mg iron isomaltoside 1000

Updated 5 times since 2017 Last updated: Jun 26, 2013 Started: Feb 29, 2012 Primary completion: May 31, 2012 Completion: Jul 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01213979, this PHASE1 trial focuses on Non-hematological Malignancies and remains completed. Sponsored by Pharmacosmos A/S, it has been updated 5 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Feb 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pharmacosmos A/S

Data source: Pharmacosmos A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.