Ferric Derisomaltose for Gynecologic Cancers

(FORGE II Trial)

Recruiting at 1 trial location

Overseen By Michelle Kan

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: AHS Cancer Control Alberta

Must not be taking: Erythropoietin, IV iron, Immunosuppressants, others

Disqualifiers: Iron overload, Liver disease, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an iron treatment called ferric derisomaltose for individuals undergoing surgery for gynecologic cancers, such as ovarian or uterine cancer. The researchers aim to determine if this treatment can boost iron levels before surgery, potentially reducing the need for blood transfusions and lowering the risk of complications. The trial compares the iron treatment to a placebo to assess its effectiveness. Suitable participants are those with low iron levels planning major surgery for suspected or confirmed gynecologic cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapy or receiving renal dialysis, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ferric derisomaltose is generally well-tolerated by patients. A large study involving 2,468 patients found it to be an effective and safe intravenous iron treatment, with few side effects. Another study examined cancer patients receiving chemotherapy and found that ferric derisomaltose helped manage anemia (a condition characterized by insufficient healthy red blood cells) without causing major problems.

Overall, these studies suggest that ferric derisomaltose is a safe option for treating iron deficiency. While no treatment is completely without risk, this iron therapy has promising safety data. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for gynecologic cancers?

Ferric Derisomaltose is unique because it offers a new way to manage iron levels in patients with gynecologic cancers. Unlike traditional iron supplements that are often taken orally and can cause digestive issues, Ferric Derisomaltose is delivered intravenously, which can lead to faster and more efficient absorption. This method helps in quickly replenishing iron without overwhelming the digestive system. Researchers are excited because this could help improve patients' overall health and readiness for surgery, potentially leading to better treatment outcomes.

What evidence suggests that ferric derisomaltose might be an effective treatment for gynecologic cancers?

Research has shown that ferric derisomaltose effectively treats anemia in patients with gynecologic cancers. Anemia, a condition where there aren't enough healthy red blood cells, is common in these patients. Ferric derisomaltose, an iron treatment administered through an IV, quickly increases hemoglobin levels, the protein in blood that carries oxygen. Studies have found that this treatment reduces the need for blood transfusions, which carry risks like infections and longer hospital stays. In this trial, some participants will receive ferric derisomaltose, while others will receive a placebo. This makes ferric derisomaltose a promising option for improving surgery outcomes in patients with gynecologic cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with iron-deficiency anemia who are scheduled for elective major gynecologic oncology surgery within the next 28-90 days. They must have low hemoglobin and transferrin saturation levels, not be pregnant, and agree to use contraception. Exclusions include other causes of anemia, hypersensitivity to the drug being tested, certain infections or liver diseases, recent iron therapy or erythropoietin use, pregnancy/lactation, psychiatric/social issues affecting compliance.

Inclusion Criteria

I received the study treatment between 21 and 90 days before my scheduled surgery.

Signed written informed consent prior to initiation of any study specific activities/procedures

WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment

Exclusion Criteria

My cervical cancer is at stage 2A or more advanced.

I have a long-term liver condition or active hepatitis.

You have anemia caused by something other than the condition being studied, such as a deficiency in B12 or folate, or a blood disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive intravenous ferric derisomaltose or placebo to correct pre-operative iron-deficiency anemia

21-90 days

1 visit (in-person)

Surgery

Participants undergo gynecologic oncology surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of postoperative complications and quality of life

28-60 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Ferric Derisomaltose
• Placebo

Trial Overview The trial tests if ferric derisomaltose can correct pre-operative iron-deficiency anemia better than a placebo in patients undergoing surgery for gynecologic malignancy. It's randomized and double-blinded; participants won't know if they're getting the actual drug or a dummy treatment.

How Is the Trial Designed?

Group I: Iron Therapy Arm Experimental Treatment 1 Intervention

500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.

Group II: Placebo Arm Placebo Group 1 Intervention

100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Ferric Derisomaltose is already approved in United States, European Union for the following indications:

Approved in United States as Monoferric for:

• Iron deficiency anemia in adults with intolerance to oral iron or unsatisfactory response to oral iron or non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Approved in European Union as Monofer for:

• Iron deficiency anemia in adults with intolerance to oral iron or unsatisfactory response to oral iron or non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

Ferric derisomaltose is an effective intravenous iron treatment that allows for complete iron repletion in a single high-dose infusion, making it a rapid and cost-effective option for patients with iron deficiency.

It has a good safety profile, with rare occurrences of serious reactions like anaphylaxis and lower rates of hypophosphatemia compared to older intravenous iron formulations, indicating its suitability for a wide range of patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of ferric derisomaltose as a treatment for anemia. Kassianides, X., Bodington, R., Bhandari, S.[2021]

In a large study of 7354 patients receiving ferric derisomaltose (FDI) for iron deficiency, the incidence of adverse reactions was very low, with only 1.7% experiencing any reactions and less than 0.1% having anaphylaxis, indicating that FDI is a safe treatment option.

Significant improvements in hemoglobin and ferritin levels were observed by Month 4 post-infusion, particularly in patients from surgical specialties, suggesting that FDI is effective in increasing iron levels in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience of intravenous ferric derisomaltose evaluated through safety and efficacy reporting in the UK. Sinclair, RCF., Nadaraja, S., Kennedy, NA., et al.[2023]

In a study of 30 cancer patients with gastrointestinal tumors undergoing chemotherapy, intravenous iron (ferric carboxymaltose) significantly improved hemoglobin levels and other iron status parameters over a treatment period of 12-14 weeks.

The treatment was well tolerated, with only one reported adverse event, indicating that ferric carboxymaltose is a safe and effective option for managing iron-deficiency anemia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of intravenous iron in the treatment of anemia in patients with gastrointestinal tract tumors undergoing chemotherapy: a single-center, observational study. Lima, J., Gago, P., Rocha, M., et al.[2022]

Ferric derisomaltose (FDI) significantly increased hemoglobin levels in Japanese patients with iron-deficiency anemia (IDA) related to gastrointestinal diseases, with an average increase of 4.33 g/dL across all participants in a phase III study involving 40 patients.

The treatment was found to be safe, with 60% of patients experiencing treatment-emergent adverse events, but no serious or unexpected safety issues were reported, indicating a favorable safety profile for both intravenous bolus injection and drip infusion methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ferric derisomaltose for iron-deficiency anemia associated with gastrointestinal diseases: a single-arm, randomized, uncontrolled, open-label study. Kawabata, H., Tamura, T., Tamai, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10649621/

Ferric derisomaltose and Outcomes in the Recovery of ... This study will provide data on efficacy and feasibility of a novel treatment with the potential to impact outcomes of gynaecological cancer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05467319

Ferric Derisomaltose/Iron Isomaltoside and Outcomes in ... Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion ...

3. cureus.com cureus.com/articles/413498-efficacy-and-safety-of-intravenous-ferric-derisomaltose-for-chemotherapy-induced-anemia-a-single-center-retrospective-study-in-japan

Efficacy and Safety of Intravenous Ferric Derisomaltose for ... It is estimated that 30-90% of patients with solid tumors and 26-85% of those with gynecologic cancers develop anemia during chemotherapy [1-3].

4. bmjopen.bmj.com bmjopen.bmj.com/content/13/11/e074649.share

Ferric derisomaltose and Outcomes in the Recovery of ... Ferric derisomaltose and Outcomes in the Recovery of Gynecologic oncology: ERAS (Enhanced Recovery After Surgery) (FORGE) – a protocol for a pilot ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05407987

Study Details | NCT05407987 | Ferric Derisomaltose and ... This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11982194/

Real-world evaluation of an intravenous iron service for the ... This retrospective audit assessed the effectiveness and safety of ferric derisomaltose (FDI), a high-dose IV iron, in 2,468 patients.