A study to investigate the efficacy and safety of Injectafer® (ferric carboxymaltose injection) in anemia due to cancer and chemotherapy

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2016-002021-11-HU
• Date of registration: 25/05/2016
• Prospective Registration: Yes
• Primary sponsor: Luitpold Pharmaceuticals, Inc.
• Public title: A study to investigate the efficacy and safety of Injectafer® (ferric carboxymaltose injection) in anemia due to cancer and chemotherapy
• Scientific title: IRON CLAD: Can Iron Lessen Anemia Due to cancer and chemotherapy: A multicenter, randomized, double-blinded, controlled study to investigate the efficacy and safety of Injectafer® (ferric carboxymaltose injection).
• Date of first enrolment: 13/07/2016
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002021-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Georgia, Hungary, Poland, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Luitpold Pharmaceuticals, Inc.

• Name: Clinical Trial Information
• Affiliation: Luitpold Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects (male or female) = 18 years of age able to give informed consent to the study
2. Subjects with solid tumors that have metastasized
3. Receiving chemotherapy as part of their cancer treatment, with at least 4 weeks of treatment remaining
4. Screening visit central laboratory hemoglobin (Hgb) <11 g/dL, but =8 g/dL
5. Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) = 35%
6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
7. Life expectancy of at least 6 months
8. Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required
assessments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
1. Previous participation in a ferric carboxymaltose clinical trial
2. Known hypersensitivity reaction to any component of ferric carboxymaltose
3. Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents)
4. Patients on erythropoiesis-stimulating agents
5. Requiring dialysis for the treatment of chronic kidney disease
6. Any non-viral infection
7. Patients with overt bleeding
8. Known positive hepatitis with evidence of active disease
9. Received an investigational drug within 30 days of screening
10. Alcohol or drug abuse within the past 6 months
11. Hemochromatosis or other iron storage disorders
12. Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the
subject's disease management at risk or may result in the subject being unable to comply with study requirements.
13. Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study.).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

cancer- and chemotherapy-related anemia
MedDRA version: 19.1 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851

Intervention(s)

Trade Name: Injectafer
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The primary objective of this study is to compare the efficacy and safety of ferric carboxymaltose (FCM) versus placebo as monotherapy for maintaining hemoglobin (Hgb) levels in patients with cancer- and chemotherapy-related anemia

Primary end point(s): Percentage of patients with a decrease in Hgb = 0.5 g/dL from baseline (Day 0 value) beginning at Week 3 through Week 18:
- If the patient’s Hgb decrease is between 0.5-1.0 g/dL from baseline, two consecutive Hgb values will be needed to qualify as part of the primary endpoint
- If the patient’s Hgb decrease is > 1.0 g/dL from baseline, on will be needed to qualify as part of the primary endpoint

Secondary Objective: Secondary objectives:
- To evaluate the safety and tolerability of FCM
* Percentage of adverse events and serious adverse events
- To evaluate the percentage of patients with a hemoglobin stabilized throughout the study
- To evaluate transfusion rate (The decision of when to transfuse will be at the discretion of the Investigator and treating physicians. However, investigators and treating physicians will be encouraged not to transfuse patients whose measured [Hgb] is greater than 7.0 g/dL in absence of any evidence of inadequate oxygen delivery to organs that could be due to [Hgb].)
* Percentage of patients receiving a transfusion
- To evaluate quality of life
* FACIT-Fatigue scale
- To evaluate efficacy response based on hepcidin levels

Timepoint(s) of evaluation of this end point: from baseline (Day 0 value) beginning at Week 3 through Week 18

Secondary Outcome(s)

Secondary end point(s): 1. Percentage of patients with avoidance of anemia progression as defined as initiation of other anemia management at any time during the study (i.e. ESAs, blood transfusions, and iron)
2. Percentage of patients with a decrease in Hgb = 0.5 g/dL from their baseline between Day 0 to each study visit
3. Time to a decrease in Hgb = 0.5 g/dL from their baseline between Day 0 to Week 18
4. Percentage of patients requiring a blood transfusion
5. Mean change in Hgb from baseline to week 18 or time of intervention
6. Percentage of patients with Hgb >1 g/dL increase at any time point in the absence of any blood transfusion or ESA treatment
7. Percentage of patients with Hgb >12 at any time point in the absence of any blood transfusion or ESA treatment
8. Time to hemoglobin response defined as = 1 g/dL increase
9. Correlation of change in hemoglobin with Day 0 hepcidin level
10. Total score of the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue)
11. Adverse eventsood transfusion or ESA treatment

Timepoint(s) of evaluation of this end point: 1. at any time during the study
2. between Day 0 to each study visit
3. between Day 0 to Week 18
4. at any time during the study
5. whole study duration
6. at any time point
7. at any time point
8. whole study duration
9. Week 2, and either at Week 18 or the time of intervention (e.g. administration of oral or IV Iron, ESAs, or transfusion)
10. whole study duration
11. whole study duration

Secondary ID(s)

1VIT14039

Source(s) of Monetary Support

Luitpold Pharmaceuticals, Inc. Clinical Research and Development