Anemia, Cancer
Conditions
Brief summary
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
Detailed description
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.
Interventions
intravenous iron formulation
Sponsors
Hikma Pharmaceuticals LLC
King Hussein Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Median Hb Change From Baseline to Week 12 | up to 12 weeks | 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). |
| Percentage of Patients With Hb Increment of at Least 1.0 gm/dL. | up to 12 weeks | 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). |
| Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL) | up to 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate in Relation to Baseline Iron Deficiency Status | up to 12 weeks | 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). |
| Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment | up to 12 weeks | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (Ferrinject) 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
Ferric carboxymaltose (FCM): intravenous iron formulation | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | Ferric Carboxymaltose (Ferrinject) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 20 Participants | — |
| Age, Categorical Between 18 and 65 years | 64 Participants | — |
| Age, Continuous | 53.8 years STANDARD_DEVIATION 10.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Jordan | 84 participants | — |
| Sex: Female, Male Female | 70 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 34 |
| other Total, other adverse events | 17 / 26 | 6 / 24 | 16 / 34 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 0 / 34 |
Outcome results
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).
Time frame: up to 12 weeks
Population: count of patients achieving correction of anemia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia | Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL) | 20 Participants |
| Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency | Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL) | 17 Participants |
| Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia | Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL) | 18 Participants |
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).
Time frame: up to 12 weeks
Population: Response defined as a Hb increment ⩾1.0gm/dL
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia | Percentage of Patients With Hb Increment of at Least 1.0 gm/dL. | 21 Participants |
| Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency | Percentage of Patients With Hb Increment of at Least 1.0 gm/dL. | 17 Participants |
| Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia | Percentage of Patients With Hb Increment of at Least 1.0 gm/dL. | 12 Participants |
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).
Time frame: up to 12 weeks
Population: median Hb change from baseline to week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia | The Median Hb Change From Baseline to Week 12 | 2.35 gm/dl |
| Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency | The Median Hb Change From Baseline to Week 12 | 1.5 gm/dl |
| Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia | The Median Hb Change From Baseline to Week 12 | 0.5 gm/dl |
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
Time frame: up to 12 weeks
Population: Percentage of patients who will require blood transfusion or ESA treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia | Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment | 6 Participants |
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).
Time frame: up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Carboxymaltose (Ferinject) in Patients With Absolute Iron Deficiency Anemia | Response Rate in Relation to Baseline Iron Deficiency Status | 21 Participants |
| Ferric Carboxymaltose (Ferinject) in Patients With Functional Iron Deficiency | Response Rate in Relation to Baseline Iron Deficiency Status | 17 Participants |
| Others-Ferric Carboxymaltose(Ferinject) in Patients With Anemia | Response Rate in Relation to Baseline Iron Deficiency Status | 12 Participants |