NCT04552288已完成2 期
Phase II Study of IL-5-receptor-alpha-chain (IL-5Rα) Inhibition With Benralizumab for Eosinophil-Related Cutaneous Adverse Events in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events
研究概览
简要总结
The purpose of this study is to find out whether the study drug benralizumab is a safe treatment that can reduce the skin side effects caused by cancer treatment by reducing the level of eosinophils in your blood. Reducing the skin side effects of your cancer treatment may improve quality of life and allow participants to continue to receive their usual cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically or cytologically confirmed solid or hematologic cancers.
- •Patient is receiving alpelisib for PIK3CA-Related Overgrowth Spectrum disorder.
- •Female and male aged 18 to 85 years, inclusively, at the time of Week 0/Day 1 of treatment.
- •Patients must have a therapy-related CTCAE grade 2/3 (See Appendix A)cutaneous adverse event defined as any cutaneous reaction listed below and blood eosinophil counts of at least .3 K/mcl.
- •Rash maculo-papular
- •Bullous dermatitis
- •Urticaria
- •Patients must plan to continue on culprit drugs (cancer patients).
- •Patients planning to receive alpelisib indicated for PIK3CA-Related Overgrowth
- •Spectrum disorder OR patients receiving immunotherapy and/or targeted therapy, including but not limited to the following agents, will be eligible for inclusion:
- •Immunotherapies: ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, atezolizumab tremelimumab.
- •Targeted therapies: trastuzumab, pertuzumab, alpelisib, osimertinib, everolimus, temsirolimus, sorafenib, regorafenib.
- •Patients using topicals/orals for indication of skin rash/pruritus for at least 7 days should continue using these drugs for the study duration
- •Adequate bone marrow, liver and renal function:
- •Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
- •Serum creatinine ≤ 1.8 xULN or calculated creatinine clearance >45 ml/min
- •Platelet count > 50 K/mcL , hemoglobin (Hb) > 8 g/dL, absolute neutrophil count (ANC) >1.0 K/mcL. Blood transfusion to meet the inclusion criteria will not be allowed.
- •ECOG performance status 0-1 (see Appendix C).
- •Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
- •Female patients are authorized to participate if they meet the following criteria:
- •Women of child bearing potential must meet both of the following conditions:
- •Have a negative serum pregnancy test prior to enrollment and within 14 days prior to administration of the investigational product (IP).
- •Patient must use an effective form of birth control (confirmed by the Investigator) throughout the study duration and within 16 weeks after last dose of IP.
- •Female subjects who cannot bear children as evidenced by one or more of the following:
- •Bilateral Oophorectomy
- •Bilateral Salpingectomy
- •Bilateral Salpingectomy-Oophorectomy
- •Hysterectomy
- •Menopause (no menses ≥ 1 year prior to treatment)
- •Surgical Sterilization (i.e., tubal ligation or blockage) Note: If criteria not met, patient should be regarded as having child bearing potential
- •Subject must be able to receive a subcutaneous injection.
- •New/worsening ercAE within 90 days prior to study enrollment. Note: This assessment will be performed by the treating investigator.
排除标准
- •Concurrent use of another investigational drug or device for the ercAE (i.e., outside of study treatment) during, or within 4 weeks of treatment.
- •Patients receiving prednisone ≥ 20mg a day.
- •Known use of anti-IL-5 agents or biologics for the treatment of asthma which are known to decrease blood eosinophil levels.
- •Patients cannot use new topicals or medications for indication of pruritus or skin rash
- •Known history of anaphylaxis to biologic therapy.
- •A helminthic parasitic infection diagnosed within 24 weeks prior to the first treatment, that had not been treated with, or has failed to respond to, standard of care therapy.
- •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
- •Active infection that would impair the ability of the patient to receive study treatment.
- •Women who are pregnant or breast-feeding.
- •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
- •Receipt of live attenuated vaccines 30 days prior to the date of randomization
- •° Receipt of inactive/killed vaccinations (e.g., inactive influenza) is allowed provided they were not administered within 1 week before/after any investigational product administration.
- •Known history of allergy or reaction to the investigational product formulation
研究组 & 干预措施
Participants with eosinophil-related cutaneous events
Experimental
Study participants will have grade 2/3 eosinophil-related cutaneous adverse events
干预措施: Benralizumab (Drug)
结局指标
主要结局
Percent Reduction in CTCAE Grade 2/3 Eosinophil-related Cutaneous Adverse Events
时间窗: 4 weeks
To evaluate the percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events to grade ≤1 resulting from checkpoint inhibitors (CPIs) or targeted therapies with absolute blood eosinophil counts of at least .3 K/mcl.
次要结局
未报告次要终点
研究者
研究点 (8)
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