Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hikma Pharmaceuticals LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
The study aims to investigate the effect of FCM (without ESAs) on anemic cancer patients undergoing chemotherapy (with or without radiotherapy); stratified by status of iron deficiency (i.e. non-iron deficient vs. iron deficient patients ). The study will also try to find out whether serum level of Hepcidin and C reactive protein can correlate with response
Patients will receive one or two doses of FCM, based on the body weight and Hb level. Patients will be followed-up for a total of twelve weeks. The study is divided into a screening, treatment and follow-up phases and is expected to be completed in 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric carboxymaltose (ferrinject) | Experimental | Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose (FCM) | Drug | intravenous iron formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in Relation to Baseline Iron Deficiency Status | Response rate in relation to baseline iron deficiency status; Patients were considered responders if they showed a minimum of 1.0 gm/dL increment in Hb level during their participation (from baseline to week 12 per patient) 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32952616 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (Ferrinject) | Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level.
Ferric carboxymaltose (FCM): intravenous iron formulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (Ferrinject) | Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level.
Ferric carboxymaltose (FCM): intravenous iron formulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | median Hb change from baseline to week 12 | Posted | Median | Full Range | gm/dl | up to 12 weeks |
|
up to 12 weeks from drug administration
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia | 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) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypophosphatemia | Investigations | CTCAE (4.0) | Non-systematic Assessment | hypophosphatemia |
study population is small, and some caution is required before generalizing study results
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hikmat Abdel-Razeq | King Hussein Cancer Center | 0096265300460 | 1403 | habdelrazeq@khcc.jo |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2016 | Nov 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2019 | Oct 23, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
Not provided
Not provided
Not provided
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
Not provided
Not provided
Not provided
Not provided
| up to 12 weeks |
| Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment | Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL | up to 12 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency | 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). |
| OG002 | Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia | 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). |
|
|
| Primary | 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). | Response defined as a Hb increment ⩾1.0gm/dL | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Primary | 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). | count of patients achieving correction of anemia | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Secondary | Response Rate in Relation to Baseline Iron Deficiency Status | Response rate in relation to baseline iron deficiency status; Patients were considered responders if they showed a minimum of 1.0 gm/dL increment in Hb level during their participation (from baseline to week 12 per patient) 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). | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Secondary | Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment | Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL | Percentage of patients who will require blood transfusion or ESA treatment | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 17 |
| 26 |
| EG001 | Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency | 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) | 0 | 24 | 0 | 24 | 6 | 24 |
| EG002 | Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia | 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) | 0 | 34 | 0 | 34 | 16 | 34 |
Not provided
Not provided
Not provided