EUCTR2010-019001-42-BG进行中（未招募）不适用
A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects with Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel) - NA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Patients with histologically or cytologically confirmed breast cancer scheduled
- •to receive doxorubicin 60 mg/m2 and docetaxel 75 mg/m2
- •2. 18 years of age or older
- •3. Adequate hematologic function: ANC >/= 1.5 x 10 9/L; Platelets >/= 100 x10 9/L
- •4. Adequate hepatic and renal function:Serum creatinine < 2.0 mg/dL; Total bilirubin within normal limits; Serum transaminases - SGOT and SGPT < 1.5 x upper
- •limit normal; Alkaline phosphatase < 2.5 x upper limit normal
- •5. ECOG performance status 0 - 2
- •6. Eligible to receive doxorubicin based on a left ventricular ejection fraction
- •(LVEF) >/= lower limit of normal for the local institution
- •7. Have the ability to understand the requirements of the study, provide written
- •informed consent (including consent for the use and disclosure of researchrelated
- •health information), and comply with the study protocol procedures
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. More than 1 prior chemotherapy regimen (including adjuvant therapy if given
- •within the last 12 months prior to study chemotherapy)
- •2. Prior lifetime cumulative anthracycline dose exceeding 240 mg/m2 doxorubicin
- •or the equivalent dose of another anthracycline or anthracenedione
- •3. Prior chemotherapy/immunotherapy within 30 days prior to study
- •chemotherapy (within 6 weeks of study chemotherapy for nitrosoureas (BCNU,
- •CCNU) or mitomycin-C)
- •4. Concomitant trastuzumab (Herceptin)
- •5. Received any investigational agent within 30 days prior to study chemotherapy
- •6. Myocardial infarction within 6 months prior to study chemotherapy,
- •uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG
- •abnormalities that may interfere with the accurate assessment of the QT
- •interval, including intraventricular conduction delays (QRS >120 msec) and
- •complete bundle branch blocks
- •7. Prior surgery within 2 weeks of study chemotherapy
- •8. Prior radiation therapy within 4 weeks of study chemotherapy (except spot
- •irradiation for bone metastases)
- •9. Prior high-dose chemotherapy with hematopoietic stem cell transplant
- •10. Prior use of G-CSF, GM-CSF or erythropoietin within 4 weeks of study
- •chemotherapy
- •11. Received systemic antibiotics within 72 hours of study chemotherapy
- •12. History of myeloid malignancy or myelodysplasia
- •13. Known brain metastases unless adequately treated (surgery or radiotherapy), no
- •evidence of progression with a minimum of 3 weeks observation and
- •neurologically stable off anticonvulsants and steroids.
- •14. Known sickle cell disease
- •15. Diagnosis of ARDS
- •16. Known history of allergies to yeast-derived products
- •17. Known hypersensitivity to E. coli-derived proteins‚ pegfilgrastim‚ filgrastim, or
- •any other component of pegfilgrastim
- •18. History of severe hypersensitivity reactions to docetaxel or other drugs
- •formulated with polysorbate 80 such as etoposide and vitamin E
- •19. Hypersensitivity to doxorubicin, any of its excipients, or other anthracyclines or
- •anthracenediones
- •20. Pregnant female or nursing mother. All non-sterile or non-postmenopausal
- •females must have a negative serum pregnancy test at screening and must
- •practice a medically accepted method of contraception over the course of the
- •study and for 30 days after the last dose of study drug (acceptable methods of
- •birth control in this study are: surgical sterilization, intrauterine devices, oral
- •contraceptive, contraceptive patch, long-acting injectable contraceptive,
- •partner’s vasectomy, a double-protection method (condom or diaphragm with
- •spermicide). Hormonal contraception must be accompanied by an additional
- •barrier method of birth control (condom).
- •21. Males who do not agree to use effective contraception throughout the study and
- •for a period of 30 days after the last dose of study drug
- •22. Known HIV positive or active hepatitis (Patients with unknown status will not
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)Postoperative Nausea and VomitingMedDRA version: 8.1 Level: LLT Classification code 10036238EUCTR2006-001761-42-LTMerck & Co., Inc700
进行中（未招募）
1 期
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)Postoperative Nausea and VomitingClassification code 10036238EUCTR2006-001761-42-ATMerck Sharp & Dohme GesmbH700
进行中（未招募）
1 期
Randomized, Blinded Trial to compare a Single Injection of Cingal® (Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide) with Cross-Linked Sodium Hyaluronate alone and with Triamcinolone Hexacetonide alone for Providing Symptomatic Relief of Osteoarthritis of the KneeOsteoarthritis of the KneeMedDRA version: 20.0Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859EUCTR2017-000355-46-PLAnika Therapeutics, Inc.576
进行中（未招募）
1 期
A study to evaluate the long-term safety and tolerability of SEP-363856 compared with an approved medicine in subjects with schizophrenia.MedDRA version: 20.0Level: LLTClassification code 10039632Term: Schizophrenia NOSSystem Organ Class: 100000004873SchizophreniaEUCTR2019-002259-40-ROSunovion Pharmaceuticals Inc.300
进行中（未招募）
1 期
A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to MethotrexateMedDRA version: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2013-001492-20-PTovo Nordisk A/S42