Clinical trial • Oncology

FERRIC CARBOXYMALTOSE for Gastric cancer

Clinical trial of FERRIC CARBOXYMALTOSE for Gastric cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastric cancer
Drug Modality
Other

Key dates

Initial CTIS Submission Date
03-12-2024
First CTIS Authorization Date
16-12-2024

Trial design

Natriumklorid 9 mg/ml “Fresenius Kabi“ (placebo), solution for infusion, max total dose 100 ml-controlled trial across 1 site in Finland.

Comparator
Natriumklorid 9 mg/ml “Fresenius Kabi“ (placebo), solution for infusion, max total dose 100 ml
Target Sample Size
202

Eligibility

Recruits 202 No vulnerable populations selected. Participants are adults only. No special consent or assent handling for vulnerable groups is described in the record..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
No vulnerable populations selected. Participants are adults only. No special consent or assent handling for vulnerable groups is described in the record.

Inclusion criteria

  • {"criterion_text":"- Adult patients with gastric cancer"}

Exclusion criteria

  • {"criterion_text":"- Patients under 18 years old"}
  • {"criterion_text":"- Patients not in full understanding"}
  • {"criterion_text":"- Hemoglobin levels > 155 g/l for women and >167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively."}
  • {"criterion_text":"- Transferrin saturation level >50%"}
  • {"criterion_text":"- Emergency gastrectomy"}
  • {"criterion_text":"- Palliative gastrectomy"}
  • {"criterion_text":"- Acute bacterial infection"}
  • {"criterion_text":"- Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products"}
  • {"criterion_text":"- Clinical evidence of iron overload or disturbances in the utilisation of iron"}
  • {"criterion_text":"- Patients <35 kg"}
  • {"criterion_text":"- Dialysis therapy for chronic renal failure"}
  • {"criterion_text":"- Hemochromatosis"}
  • {"criterion_text":"- Polycytemia vera"}
  • {"criterion_text":"- Pregnancy"}
  • {"criterion_text":"- Patients in need of direct blood transfusion"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of patients receiving transfusions","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Postoperative Hb level, complications and quality of life","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
202
Recruitment Window Months
92

Geography

Total Number Of Sites
1
Total Number Of Participants
202

Finland

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
13
Number Of Sites
1
Number Of Participants
202

Sites

Site Name
HUS-Yhtymae
Department Name
Department of Upper GI Surgery
Principal Investigator Name
Arto Kokkola
Principal Investigator Email
arto.kokkola@hus.fi
Contact Person Name
Arto Kokkola
Contact Person Email
arto.kokkola@hus.fi

Sponsor

Primary sponsor

Full Name
HUS-Yhtymae
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Third parties

  • {"country":"","full_name":"Helsinki University Hospital Research Fund","duties_or_roles":"Source of monetary support","organisation_type":""}
  • {"country":"","full_name":"Helsinki University Research Fund","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Ferinject 50 mg Fe/ml injektio-/infuusioneste, dispersio.
Active Substance
FERRIC CARBOXYMALTOSE
Modality
Other
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 22144; authorisationCountryCode: FI)
Maximum Dose
2 g
Investigational Product Name
Natriumklorid 9 mg/ml “Fresenius Kabi“
Active Substance
SODIUM CHLORIDE
Modality
Other
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 920244; authorisationCountryCode: IS)
Starting Dose
100 ml (max total dose)
Maximum Dose
100 ml

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