Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Digestive System Diseases

Neoplasm Metastasis

Anemia

Anemia, Iron-Deficiency

Iron Deficiencies

Inflammatory Bowel Diseases

Intestinal Diseases

Deficiency Diseases

Hematologic Diseases

Neoplastic Processes

Gastrointestinal Diseases

Gastroenteritis

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Malnutrition

Nutrition Disorders

Micronutrients

All Drugs and Chemicals

Anti-Infective Agents

Mineral

Iron

Hepcidins

Iron Supplement

2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg

Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg

Injectafer

325mg (1 tablet) three times a day for 28 days

Ferrous Sulfate tablets

Mark A Falone, MD

The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron in patients with varying hepcidin levels correlating the treatment response/hepcidin levels to more common laboratory parameters such as ferritin and CRP (C-Reactive Protein) levels and possibly determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass

Multicenter Randomized Open-label Controlled Study to Investigate Treatment Response of IV Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia Secondary to Inflammatory Bowel Disease or Gastric Bypass

Responders were defined as subjects achieving an increase from baseline ≥2 g/dL at anytime between baseline and the end of the study (Day 28). The relation between screening hepcidin and change in hemoglobin was assessed with regression models with baseline hepcidin and treatment group as independent factors. Treatment group differences (oral vs. IV iron) for mean changes in endpoints were assessed with the analysis of covariance with a fixed factor for treatment and baseline value as covariate. Treatment group differences for proportions were assessed with the normal approximation to the binomial distribution.

American Regent, Inc.

2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg

Injectafer: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg

Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days

Ferrous Sulfate Tablets

Total

Age, Continuous

Sex: Female, Male

White

Black/African American

Asian

American Indian/Alaska Native

The category of Race is Check All That Apply. In the Injectafer group, two subjects didn't check any options and one subject checked two options. In the Oral Iron group, one subject checked two options.

Race/Ethnicity, Customized

United States

Region of Enrollment

Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin

Point of Care Hemoglobin

Of the 198 subjects randomized, two subjects (one in each group) were not treated.

The study was stopped early due to slow enrollment, however it was not considered prematurely terminated. A total of 198 of the 400 subjects planned were randomized, 196 were treated, and the study concluded normally.

Angelia Butcher

Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).

Overall Study

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Participants receive a Ferric Carboxymaltose injection by vein. Dose repeated 1 week later.

Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

Participants take iron supplements by mouth every day for up to 3 months.

Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.

Ferric Carboxymaltose

Participants take iron supplements by mouth every day for up to 3 months.

Iron Supplements

Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

Questionnaire

Saroj Vadhan-Raj, MD

The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose) with an iron supplement to learn which may be more effective in improving red blood cell counts in patients who have iron-deficiency anemia (a low red blood cell count) because of a gastrointestinal stromal tumor (GIST) and/or systemic therapy.

The safety of ferric carboxymaltose will also be studied.

This is an investigational study. Ferric carboxymaltose is FDA approved and commercially available to treat iron deficiency anemia; however, it is considered investigational to use in patients who have cancer-related or systemic therapy-related anemia.

Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is better, the same, or worse than the other.

* If you are in Group A, you will receive ferric carboxymaltose injection by vein over about 15 minutes. You will receive 2 injections about 7 days apart (for example, on Days 0 \[the day you are assigned to a study group\] and 7).
* If you are in Group B, you will take iron supplements by mouth every day. This is considered standard of care for iron deficiency anemia and the study staff will discuss with you which iron supplements you will take and their risks.

You and the study staff will know to which group you are assigned.

Length of Study:

You may receive up to 2 injections of ferric carboxymaltose (if you are in Group A) or up to 3 months of oral iron supplements (if you are in Group B). You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over after you have completed the Week 24 visit.

Study Visits:

Baseline (within 1 week after you have been assigned to a study group):

* You will have a physical exam.
* You will complete a questionnaire about your health. It should take about 5 minutes to complete.
* Blood (about 1 tablespoon) will be drawn for routine tests and to test the level of iron in your blood.

One (1) time every week during Months 1-3, blood (about 1 tablespoon) will be drawn for routine tests.

At about Weeks 4, 8, 12, and 24 (the end-of-study visit):

* You will have a physical exam (Weeks 12 and 24 only).
* You will complete the same questionnaire you did at baseline.
* Blood (about 1 tablespoon) will be drawn for routine tests and to test the level of iron in your blood.

During Weeks 16 and 20, blood (less than 1 tablespoon) will be drawn to test the level of iron in your blood.

If you leave the study before Week 24, you will have the Week 24 study visits as soon as possible after you leave the study.

Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy

The primary endpoint is response (CR rate) in HGB within 3 months. Participant considered as to have a complete response (CR) if his/her HGB level increases \> 2 g/dL from baseline during 3 months following initiation of the study drug, and/or transfusion-dependent patient is transfusion free.

M.D. Anderson Cancer Center

Participants receive a Ferric Carboxymaltose injection by vein. Dose repeated 1 week later.

Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

Ferric Carboxymaltose: 15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.

Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

Group A - Ferric Carboxymaltose

Participants take iron supplements by mouth every day for up to 3 months.

Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

Iron Supplements: Participants take iron supplements by mouth every day for up to 3 months.

Questionnaire: Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.

Group B - Iron Supplement

Age, Categorical

Ethnicity (NIH/OMB)

Saroj Vadhan,Clinical Professor, Cytokine & Supportive Oncology

Due to early termination of the protocol and low accrual not enough data collected to analyze the Complete Response Rate in Hemoglobin.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass	NCT02086968	Iron Deficiency...	Injectafer Ferrous Sulfate...	18 Years -	American Regent, Inc.
Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy	NCT02949947	Malignant Neopl... Gastrointestina...	Ferric Carboxym... Iron Supplement... Questionnaire	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for injectafer

Every month we try and update this database with for injectafer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for injectafer

Every month we try and update this database with for injectafer cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for injectafer cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.