BridgeMD
New treatment option for Gynecologic Cancer
Official title Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
ClinicalTrials.gov ID: NCT05407987
What this study is testing
What is Ferric derisomaltose?
Ferric derisomaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gynecologic cancer.
Also referred to as MONOFERRIC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Signed written informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years old.
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- The indication for the operation may be for suspected or proven gynecologic malignancy.
- Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1.
You likely can't join if
- Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%.
- Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).
- Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
- Temperature \>38C or patient on non-prophylactic antibiotics.
- Known chronic liver disease or active hepatitis.
- Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
See the full eligibility criteria
- Signed written informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years old.
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- The indication for the operation may be for suspected or proven gynecologic malignancy.
- Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1.
- The expected time from recruitment to surgery is 28-90 days.
- Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%.
- Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
- Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).
- WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
- Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks.
- Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%.
- Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).
- Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
- Temperature \>38C or patient on non-prophylactic antibiotics.
- Known chronic liver disease or active hepatitis.
- Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
- Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range.
- Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo).
- Unfit for elective surgery.
- Pregnancy or lactation. 1\. Unable to fully comprehend and/or perform study procedures and patients with psychiatric illness/social situations/substance abuse that would limit compliance with study requirements. 11\...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.