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

NCT02949947 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-04-06

Study results available
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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.

Conditions

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

Interventions

DRUG

Ferric Carboxymaltose

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

DIETARY_SUPPLEMENT

Iron Supplements

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

BEHAVIORAL

Questionnaire

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

Sponsors & Collaborators

  • American Regent, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Saroj Vadhan-Raj, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2019-03-06
Completion
2019-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02949947 on ClinicalTrials.gov