Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

NCT04246021 | Completed Results

• 1 other identifier: PRT-INM-0615/09
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

Conditions

Anemia; Cancer

Outcome Measures

Primary Outcomes (3)

• The Median Hb Change From Baseline to Week 12

  The median Hb change from baseline to week 12 per patient in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

  up to 12 weeks

• Percentage of Patients With Hb Increment of at Least 1.0 gm/dL.

  Percentage of patients with Hb increment of at least 1.0 gm/dL during their participation (from baseline to week 12 per patient) in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

  up to 12 weeks

• Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL)

  Percentage of patients achieving correction of anemia (Hb \>11.0 gm/dL) during their participation (from baseline to week 12 per patient) in the three groups. A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).

  up to 12 weeks

Secondary Outcomes (2)

• Response Rate in Relation to Baseline Iron Deficiency Status

  up to 12 weeks

• Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment

  up to 12 weeks

Study Arms (1)

Ferric carboxymaltose (ferrinject)

EXPERIMENTAL

Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level. * Ferric carboxymaltose will be administered as a single infusion if the needed dose is 1000 mg as a short IV infusion * If the needed Ferric carboxymaltose dose is \> 1000 mg, an initial dose of 1000 mg will be given as a short IV infusion and the remaining dose will be given the week after in a similar fashion

Drug: Ferric carboxymaltose (FCM)

Interventions

Ferric carboxymaltose (FCM) DRUG

intravenous iron formulation

Also known as: Ferinject

Ferric carboxymaltose (ferrinject)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is an adult more than or equal 18 years old at the time of informed consent.
• Patient has pathologic diagnosis of solid tumor (breast cancer, colorectal, lung, sarcoma, head and neck, sarcoma, genitourinary or gynecological cancer).
• Patients who started chemotherapy (with or without radiotherapy) or planned to receive chemotherapy for at least 12 weeks.
• Patient has an Eastern Cooperative Oncology Group performance status between 0 and 2.
• Patient with Hb ≤11 g/dL.
• Patient has a Life expectancy at least 6 months.
• Adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum Creatinine level of less than 2 mg per deciliter.
• Patient is able to understand and provide informed consent to participate in the study.

You may not qualify if:

• Patient has Hb \< 8.0 g/dL
• Patient presenting with hematologic malignancy including
• Prior gastric surgery.
• Patients on definitive radiotherapy alone.
• Patients with relevant history (within six weeks) or clinical evidence of hemolysis or active bleeding that could, in the investigator's judgment, be a potential cause for the anemia (no gross hematuria, hemoptysis, hematochezia or melena and negative stool for hemoccult)
• Presence of other nutritional anemia; deficiency of vitamin B12 less than 187 pg/ml and deficiency of Folate less than 3.1 ng/ml according to the local laboratory normal ranges
• Patient has Iron overload (Serum Ferritin more than 800 ng/ml or Transferrin saturation (TSAT) more than 40%)
• Patient is pregnant or lactating.
• Patient has a personal or family history of hemochromatosis.
• Patient has hypersensitivity to any form of IV iron.
• Patient has received red blood cells transfusion or used erythropoietin within 2 weeks of enrollment into the study.
• Patient has received any form of intravenous iron within the last 12 weeks
• Patient has received oral iron supplements within 1 month of enrollment to the study, except for multivitamin supplements containing less than 30 mg iron.

Sponsors & Collaborators

• King Hussein Cancer Center: lead
• Hikma Pharmaceuticals LLC: collaborator

Related Publications (1)

• Abdel-Razeq H, Saadeh SS, Malhis R, Yasser S, Abdulelah H, Eljaber R, Kleib A, Ismael R. Treatment of anemia in cancer patients undergoing chemotherapy with intravenous ferric carboxymaltose without erythropoiesis-stimulating agents. Ther Adv Med Oncol. 2020 Sep 9;12:1758835920953292. doi: 10.1177/1758835920953292. eCollection 2020.

  PMID: 32952616 RESULT

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

study population is small, and some caution is required before generalizing study results

Results Point of Contact

• Title: Dr. Hikmat Abdel-Razeq
• Organization: King Hussein Cancer Center

habdelrazeq@khcc.jo

0096265300460

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer and Deputy Director General King Hussein Cancer Center

Model Details: This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: January 29, 2020
• Study Start: June 15, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 4, 2022
• Results First Posted: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share