Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Complete Response Rate in Hemoglobin (HGB)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A - Ferric Carboxymaltose
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.
干预措施: Ferric Carboxymaltose (Drug)
Group A - Ferric Carboxymaltose
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.
干预措施: Questionnaire (Behavioral)
Group B - Iron Supplement
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.
干预措施: Iron Supplements (Dietary Supplement)
Group B - Iron Supplement
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.
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Complete Response Rate in Hemoglobin (HGB)
时间窗: 3 months
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.
次要结局
未报告次要终点