KCT0004194尚未招募未知
Phase 2, open label, intra-patient trial of peg-filgrastim to Reduce the non-hematological toxicity and improve patient reported outcome in the patients with Breast cancer
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- o Limit 至 65(Year)（—）
- 性别
- Female
入选标准
- •1. Histologically or cytologically confirmed breast cancer patients
- •3. Under 65 age
- •4. Patients who have received or are scheduled to receive surgical treatment for a cure
- •5. Patients receiving anthracycline-based chemotherapy for preoperative or postoperative adjuvant chemotherapy.
- •6. Physical functions appropriate for treatment
- •a. Absolute neutrophil count (ANC) =1500 cells / mm3
- •b. Platelets =100,000 cells / mm3
- •c. Estimated creatinine clearance =50 mL / min, or serum creatinine <1.5 x upper limit of normal (ULN)
- •d. Bilirubin =1.5 x ULN
- •e. AST (SGOT)? 2.5 x ULN
- •f. ALT (SGPT)? 2.5 x ULN
- •g. 12-lead electrocardiogram (ECG) findings that are clinically insignificant changes that do not require normal or medical intervention.
排除标准
- •1. Male patient
- •2. Anthracycline-based chemotherapy is not appropriate for patients
- •3. Patients with severe medical conditions that are not suitable for clinical trial enrollment
- •4. Patients who are pregnant or lactating, or who do not agree to perform appropriate contraception during the trial
- •5. Patients who are unwilling or unable to agree to participate in clinical trials
研究者
相似试验
招募中
2 期
A Phase2 study of the safety and efficacy of pegfilgrastism for the prevention of febrile neutropenia in patients receiving TPF therapy for squamous cell carcinoma of the head and neck.JPRN-jRCTs031220695Saito Yuki18
尚未招募
3 期
Study of Pegylated interferon alfa-2a in combination with Lamivudine or Entecavir in children with Chronic Hepatitis BCTRI/2017/07/009027F HoffmannLa Roche Ltd114
进行中（未招募）
不适用
Clinical trial comparing AXL1717 to docetaxel in patients with previously treated, locally advanced, or metastatic squamous cell carcinoma or adenocarcinoma of the lungon-small-cell lung cancer previously treatedMedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864EUCTR2011-002007-15-HUAxelar AB140
进行中（未招募）
1 期
Peg-IFN, RBV and telaprevir vs Peg-IFN and RBV alone in patients with acute hepatitis C and HIV co-infectioAcute hepatitis C infectionEUCTR2012-005525-75-GBSt Stephen's AIDS Trust24
进行中（未招募）
1 期
A clinical trial of nebulised recombinant tissue plasminogen activator (rtPA) in patients with COVID-19 Acute Respiratory Distress Syndrome to decrease the duration of ventilatory support and mortality: A pilot study (the PACA trial)Acute respiratory distress syndrome (ARDS) caused by COVID-19EUCTR2020-001640-26-GBniversity College London36