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Iron

Iron isomaltoside 1000

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Iron Supplement

Iron isomaltoside intravenously as bolus or infusion

intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

iron isomaltoside 1000

oral, 200 mg per day (100 mg bid),12 weeks

iron sulphate

Lars Lykke Thomsen, MD

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Pharmacosmos A/S

The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

Iron Isomaltoside 1000

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Iron Sulphate

Total

Age, Categorical

Sex: Female, Male

India

Germany

Denmark

Spain

Poland

Russian Federation

Sweden

United States

Region of Enrollment

Vice President Research & Development Department

The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.

Change in Hb Concentration

Change in Hemoglobin From Baseline to Week 24

Overall Study

Neoplasms

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Stomach Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Kidney Neoplasms

Colorectal Neoplasms

Endometrial Neoplasms

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Head and Neck Neoplasms

Esophageal Diseases

Uterine Neoplasms

Uterine Diseases

Kidney Diseases

Adenocarcinoma

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Quality of Life

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Darbepoetin alfa

Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.

Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by patients receiving a specific agent in a drug class.

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \[MID\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \[MID\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (\>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL

The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \[MID\]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).

Amgen

Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.

Darbepoetin Alfa or Other ESA

Age, Continuous

The fatigue VAS is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue). Baseline VAS data were available for 1109 participants.

Fatigue-Visual Analog Scale (VAS) Score

The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. Baseline data were available for 1109 participants.

Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score

Baseline hemoglobin levels were available for 1133 participants.

Hemoglobin level

Full analysis set, defined as enrolled participants who received at least 1 dose of darbepoetin alfa or any other erythropoiesis-stimulating agent (ESA) before the end of study.

Study Director

Darbepoetin Alfa

The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.

Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL

Breast cancer (N=152)

Prostate cancer (N=39)

Small cell lung cancer (N=12)

Non-small cell lung cancer (N=70)

Colorectal cancer (N=71)

Ovarian cancer (N=79)

Bladder cancer (N=16)

Endometrial cancer (N=12)

Renal cancer (N=10)

Pancreatic cancer (N=31)

Esophogeal cancer (N=3)

Gastric cancer (N=15)

Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL

Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline

Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points

Time to First Increase in Hemoglobin

Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time

Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S
Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia	NCT01444456	Anemia Breast Cancer Cancer Colorectal Canc... Lung Cancer Ovarian Cancer Prostate Cancer Solid Tumors Bladder Cancer Endometrial Can... Renal Cancer Pancreatic Canc... Esophageal Canc... Gastric Cancer		18 Years -	Amgen
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)	NCT01145638	Non-myeloid Mal... Chemotherapy In...	iron isomaltosi... iron sulphate	18 Years -	Pharmacosmos A/S

Spots Global Cancer Trial Database for chemotherapy induced anaemia