A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Events
研究概览
简要总结
This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and without iron supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Have histological or cytological evidence of non-myeloid cancer (solid tumors, lymphomas or multiple myeloma) that is metastatic and/or incurable
- •Have been treated with at least one systemic (oral, intravenous, or subcutaneous) anti-cancer therapy or regimen
- •Have a hemoglobin of less than or equal to 11 grams/deciliter (g/dL)
- •Have a hepcidin level of greater than or equal to 5 nanograms/milliliter (ng/mL)
- •Have given written informed consent prior to any study-specific procedures
- •Have adequate hematologic, hepatic, and renal organ function
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- •Available for the duration of the study and willing to follow study procedures
- •If male or female with reproductive potential: Must agree to use medically approved contraception during the trial and for 4 months following the last dose of study drug
- •If female with child bearing potential: Have a negative serum pregnancy test
- •Have an estimated life expectancy of greater than or equal to 12 weeks
排除标准
- •Have received treatment in the previous 21 days with, or have not recovered fully from, a drug that has not received regulatory approval for any indication
- •Have received erythropoiesis-stimulating agents in the previous 21 days or red blood cell transfusions in the previous 14 days, or in the investigator's opinion, likely to need red blood cell transfusion more frequently than every 21 days
- •Have received parenteral iron supplementation within the prior 14 days
- •Have a documented history of pure red cell aplasia, thalassemia major or sickle cell disease
- •Have a history of cirrhosis or major organ transplantation
- •QTc greater than 470 millisecond (msec)
- •Have evidence of clinically significant hemolysis or bleeding
- •Have a clinically significant systemic infection within 14 days of enrollment
- •Have a suspected or confirmed history of hemochromatosis.
- •Have other serious preexisting medical conditions (left to the discretion of the investigator)
- •Have symptomatic central nervous system malignancy or metastasis (screening not required)
- •Have acute or chronic leukemia
- •Are a female who is pregnant or lactating
- •Have a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (screening not required)
- •Have received external beam radiotherapy to more than 25% of the bone marrow
- •Have known clinically significant hypersensitivity to biologic agents
- •Have received live vaccine(s) within 1 month of screening or with plans of doing that during the participation to the study
- •Have a history of congestive heart failure with New York Heart Association (NYHA) Class greater than 2 (NYHA Class 1 and 2 are eligible), unstable angina or recent myocardial infarction (within 1 year prior to administration of study drug)
研究组 & 干预措施
LY2787106 Dose Escalation
Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.
干预措施: LY2787106 (Drug)
10 mg/kg LY2787106
Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.
干预措施: LY2787106 (Drug)
10 mg/kg LY2787106+Iron
Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles with daily oral iron supplementation. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.
干预措施: LY2787106 (Drug)
10 mg/kg LY2787106+Iron
Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles with daily oral iron supplementation. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.
干预措施: Iron Supplementation (Dietary Supplement)
结局指标
主要结局
Number of Participants With Clinically Significant Events
时间窗: Baseline to Study Completion (up to 5 Years)
Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation
时间窗: Baseline, Cycle 4 (7-day cycle)
This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax)(Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion)
- PK: Area Under the Curve (AUC[0-∞])(Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion)
- Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)(Baseline to Cycle 1 of Part A)
- Change From Baseline in Serum Iron(Baseline, Cycle 4 (7-day cycle))
- Mean Change From Baseline in Reticulocyte Count(Baseline, Cycle 4 (7-day cycle))