Tittle: Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer. A double blinded clinical randomized trial.

2024-518517-26-00 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 10 Oct 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 3 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 134
Countries 1
Sites 3

Iron deficiency

Evaluation of physical capacity in patients with colorectal cancer after infusion of iron or placebo and to evaluate immunological changes in patients with colorectal cancer after infusion of iron/placebo using Neutrophil to lymphocyte ratio (NRL) and Nanostring methodology and thereby investigate the effects of intrav…

Key facts

Sponsor
Region Sjaelland
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Trial duration
10 Oct 2024 → ongoing
Decision date (initial)
2024-11-15
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518517-26-00
EudraCT number
2019-003819-56

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Evaluation of physical capacity in patients with colorectal cancer after infusion of iron or placebo and to evaluate immunological changes in patients with colorectal cancer after infusion of iron/placebo using Neutrophil to lymphocyte ratio (NRL) and Nanostring methodology and thereby investigate the effects of intravenously administered iron on both short- and long term outcomes and effects on the tumor microenviroment.

Conditions and MedDRA coding

Iron deficiency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Planned for curative intended elective colon or rectum cancer surgery
  2. UICC stage I-III
  3. Age ≥ 18
  4. Hgb > 7.0 mmol/L for both men and women.
  5. Serum ferritin ≤100 μg/L or Transferrin saturation (TSAT) ≤20 for both men and women.

Exclusion criteria 11

  1. Chronic kidney failure, with need for dialysis
  2. Metachronous diagnosed cancer
  3. Unable to speak and understand Danish
  4. Cognitive impairment e.g. moderate to severe dementia
  5. Concurrent severe active bacterial infection
  6. Known allergy of monofer
  7. Contraindication for iv. iron infusion (Porfyria cutanea tarda, Livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)
  8. Treatment with iron infusion for other reasons
  9. Withdrawal of informed consent
  10. Neoadjuvant chemo or radiation therapy
  11. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

  1. Changes in cellular respiration (VO2max at the Anaerobic Threshold) measured by the gold standard Cardio Pulmonary Exercise Testing (CPET).
  2. The preoperative change in the Neutrophil to Lymphocyte Ratio (NLR)
  3. The up and downregulation of immune function at the invasive front of the tumor, measured by the Nanostring™ PanCancer Immune® profiling panel

Secondary endpoints 3

  1. The patients subjective description of physical capacity measured by the Fatique Severity Score questionnaire
  2. Treatment characteristics such as: Adverse events, serious adverse events, blood transfusions, changes in transferrin, ferritin, transferrin saturation, iron, hemoglobin and phosphate, length of stay, infectious complications measured by the comprehensive complication index and quality of recovery-15 during the admission
  3. One and five year survival rates and recurrence rates.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Monofer, injektions- og infusionsvæske, opløsning

PRD538528 · Product

Active substance
Ferric Derisomaltose
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
1000 mg milligram(s)
Max total dose
1000 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B03AC — IRON TRIVALENT, PARENTERAL PREPARATIONS
Marketing authorisation
43747
MA holder
PHARMACOSMOS A/S
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Natriumchlorid ”Noridem”,solvens til parenteral anvendelse/injektionsvæske, opløsning

PRD388433 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
100 ml millilitre(s)
Max total dose
100 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
Marketing authorisation
41289
MA holder
NORIDEM ENTERPRISES LTD
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

14 Total trials 7 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Region Sjaelland
Address
Lykkebaekvej 1
City
Koege
Postcode
4600
Country
Denmark

Scientific contact point

Organisation
Region Sjaelland
Contact name
Lisa Aalling

Public contact point

Organisation
Region Sjaelland
Contact name
Lisa Aalling

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Sponsor responsibilities

Article 77 implementation
Region Sjaelland

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 134 3
Rest of world — 0 —

Investigational sites

Denmark

3 sites · Ongoing, recruiting
Region Sjaelland
Department of Surgery, Lykkebaekvej 1, 4600, Koege
Hvidovre Hospital
Department of Surgery, Kettegaard Alle 30, 2650, Hvidovre
Slagelse Hospital
Department of Surgery, Ingemannsvej 18, 4200, Slagelse

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-10-10 2024-10-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol sideropeni 5
Recruitment arrangements (for publication) Recruitment arrangements 1
Subject information and informed consent form (for publication) Deltagerinformation sideropeni 4
Subject information and informed consent form (for publication) Forsoegspersoners rettigheder NVK 1
Subject information and informed consent form (for publication) rbgb_patientinformationv4_20180116_godkendt 4
Subject information and informed consent form (for publication) RBGB_TilkendegivelseV6_20201123_GODKENDT 6
Subject information and informed consent form (for publication) Samtykke erklring 2

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-10 Denmark Acceptable
2024-10-31
 2024-11-15

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