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

2016-11-01 07:23:21 | BioPortfolio

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.

Description

Study Groups and Study Drug Administration:

If participant is found to be eligible to take part in this study, they 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 participant is in Group A, they will receive ferric carboxymaltose injection by vein over about 15 minutes. Participant will receive 2 injections about 7 days apart (for example, on Days 0 [the day participant is assigned to a study group] and 7).

- If participant is in Group B, they 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 participant which iron supplements they will take and their risks.

Participant and the study staff will know to which group they are assigned.

Length of Study:

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

Participation on the study will be over after participant has completed the Week 24 visit.

Study Visits:

Baseline (within 1 week after participant has been assigned to a study group):

- Participant will have a physical exam.

- Participant will complete a questionnaire about their 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 participant's blood.

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

During Weeks 4, 8, 12, and 24:

- Participant will have a physical exam.

- Participant will complete the same questionnaire they did at baseline.

- Blood (about 1 tablespoon) will be drawn for routine tests and to test the level of iron in participant's blood.

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

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Malignant Neoplasms of Mesothelial and Soft Tissue

Intervention

Ferric Carboxymaltose, Iron Supplements, Questionnaire

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-01T07:23:21-0400

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