EUCTR2019-001386-33-BE进行中（未招募）1 期
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients with Invasive Mold Infections Caused by Aspergillus Species or Rare Molds
Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer, Inc.0 个研究点目标入组 50 人开始时间: 2019年7月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males or females, 18 years or older.
- •2.Patients with proven or probable IMI caused by Aspergillus spp. Patients who present with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled.
- •Cohort A: Diagnosis of a proven or probable IMI will be defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC a modified version of the 2008 Revised Definitions of Invasive Fungal Disease from the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) Consensus Group criteria.
- •Cohort B: Diagnosis of proven or putative aspergillosis will be defined in accordance the diagnostic criteria specified in Appendix F of the protocol.
- •3.Have limited or no treatment options due to documented or anticipated resistance, contraindication, intolerance, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional/country treatment guidelines.
- •4.Patients where the Investigator considers that there is a potential advantage of using APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during antifungal prophylaxis, activity against resistant mold pathogens, IV and PO formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide tissue distribution including brain), and/or where the SOC antifungal therapy carries significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk, site of infection not accessible by SOC).
- •9.Cohort B only: Patients must have a lower respiratory tract infection due to SARS-CoV-2 or influenza A/B.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Refractory hematologic malignancy.
- •2.Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- •3.Treatment with systemic (PO, IV, or inhaled) antifungal therapy with a mold-active azole or polyene for 120 hours immediately before initial dosing. Note: patients with invasive fungal infection caused by a mold with documented resistance to or lack of coverage by the prior SOC in question, as well as patients with polyene-induced renal toxicity or those who have received empirical treatment with echinocandins, may have received >120 hours prior treatment and remain eligible for the study.
- •4.Evidence of significant hepatic dysfunction
- •13.Patients on mechanical ventilation
- •14.Cohort A only: Suspected or confirmed COVID-19 or Influenza A/B infection.
- •15. Patients with severe renal impairment as determined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.173 m2 calculated by CKD-EPI, including patients on dialysis.
- •16. Patients with a Karnofsky Performance Status = 30 at screening
研究者
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