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

Primary Purpose

Malignant Neoplasms of Mesothelial and Soft Tissue, Gastrointestinal Stromal Tumor With Neurogenic Differentiation

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ferric Carboxymaltose

Iron Supplements

Questionnaire

About this trial

This is an interventional supportive care trial for Malignant Neoplasms of Mesothelial and Soft Tissue focused on measuring Malignant Neoplasms of Mesothelial and Soft Tissue, Gastrointestinal Stromal Tumor, GIST, Iron-deficiency anemia, Ferric Carboxymaltose, Injectafer, Iron supplement, Health Questionnaire, Survey

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

GIST patients with IDA planned to start or are receiving systemic therapy with TKIs.
Evidence of iron deficiency anemia including, Hgb < 11 g/dL, but > 8 g/dL; and transferrin saturation (TSAT) < 20%.
No H/O allergic reaction to iron therapy.
No clinical signs active of bleeding.
Adequate hematologic (ANC > 1500/mm^3, platelet count > 100,000/mm^3), renal (serum creatinine < 1.5mg/dL), and hepatic (serum bilirubin count < 1.5 x normal and serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 x normal) functions.
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
Signed informed consent to the study.
Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence.
Patients are required to read and understand English to comply with protocol requirements.
Age >=18 years old.
Life expectancy of at least 6 months.

Exclusion Criteria:

Pregnant or lactating women.
Patients with any co-morbid condition which renders patients at high risk of treatment complication.
Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months.
Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years).
Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
Known hypersensitivity reaction to any component of ferric carboxymaltose.
Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, or erythropoiesis-stimulating agents), or transfusion of PRBCs in 2 weeks.
Hemochromatosis or other iron storage disorders.
Known positive hepatitis with evidence of active disease.
Patients with overt bleeding.
Ferritin >/= 800 ng/mL.

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A - Ferric Carboxymaltose

Group B - Iron Supplement

Arm Description

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.

Outcomes

Primary Outcome Measures

Complete Response Rate in Hemoglobin (HGB)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02949947

First Posted

October 27, 2016

Last Updated

March 23, 2020

Sponsor

M.D. Anderson Cancer Center

Collaborators

American Regent, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02949947

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

Terminated per PI's request

Study Start Date

December 18, 2017 (Actual)

Primary Completion Date

March 6, 2019 (Actual)

Study Completion Date

March 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

American Regent, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasms of Mesothelial and Soft Tissue, Gastrointestinal Stromal Tumor With Neurogenic Differentiation

Keywords

Malignant Neoplasms of Mesothelial and Soft Tissue, Gastrointestinal Stromal Tumor, GIST, Iron-deficiency anemia, Ferric Carboxymaltose, Injectafer, Iron supplement, Health Questionnaire, Survey

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A - Ferric Carboxymaltose

Arm Type

Experimental

Arm Description

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.

Arm Title

Group B - Iron Supplement

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ferric Carboxymaltose

Other Intervention Name(s)

Injectafer

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron Supplements

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Questionnaire

Other Intervention Name(s)

Survey

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete Response Rate in Hemoglobin (HGB)

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: GIST patients with IDA planned to start or are receiving systemic therapy with TKIs. Evidence of iron deficiency anemia including, Hgb < 11 g/dL, but > 8 g/dL; and transferrin saturation (TSAT) < 20%. No H/O allergic reaction to iron therapy. No clinical signs active of bleeding. Adequate hematologic (ANC > 1500/mm^3, platelet count > 100,000/mm^3), renal (serum creatinine < 1.5mg/dL), and hepatic (serum bilirubin count < 1.5 x normal and serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 3 x normal) functions. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. Signed informed consent to the study. Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence. Patients are required to read and understand English to comply with protocol requirements. Age >=18 years old. Life expectancy of at least 6 months. Exclusion Criteria: Pregnant or lactating women. Patients with any co-morbid condition which renders patients at high risk of treatment complication. Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months. Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years). Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up. Prior surgery or radiotherapy (RT) within 2 weeks of study entry. Known hypersensitivity reaction to any component of ferric carboxymaltose. Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, or erythropoiesis-stimulating agents), or transfusion of PRBCs in 2 weeks. Hemochromatosis or other iron storage disorders. Known positive hepatitis with evidence of active disease. Patients with overt bleeding. Ferritin >/= 800 ng/mL.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saroj Vadhan-Raj, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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