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

NCT02949947 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0588NCI-2016-01925
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Group A - Ferric Carboxymaltose

EXPERIMENTAL

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.

Drug: Ferric Carboxymaltose; Behavioral: Questionnaire

Group B - Iron Supplement

ACTIVE COMPARATOR

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.

Dietary Supplement: Iron Supplements; Behavioral: Questionnaire

Interventions

Ferric Carboxymaltose DRUG

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

Also known as: Injectafer

Group A - Ferric Carboxymaltose

Iron Supplements DIETARY_SUPPLEMENT

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

Group B - Iron Supplement

Questionnaire BEHAVIORAL

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

Also known as: Survey

Group A - Ferric Carboxymaltose; Group B - Iron Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Hemochromatosis or other iron storage disorders.
• Known positive hepatitis with evidence of active disease.
• Patients with overt bleeding.
• Ferritin \>/= 800 ng/mL.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Regent, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Plexosarcoma; Gastrointestinal Stromal Tumors; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Iron-Dextran Complex; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Saroj Vadhan,Clinical Professor, Cytokine & Supportive Oncology
• Organization: UT MD Anderson Cancer Center

svadhanr@mdanderson.org

(713) 792-7966

Study Officials

• Saroj Vadhan-Raj, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: October 31, 2016
• Study Start: December 18, 2017
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-03

Locations

US (1)