EUCTR2013-001550-98-DE进行中（未招募）1 期
Prospective controlled phase 2 trial of cabazitaxel in patients with temozolomide refractory glioblastoma multiforme (GBM)- The C-GBM Study
niversity Hospital of Ulm0 个研究点开始时间: 2013年7月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •· Patients with diagnosis glioblastoma multiforme (GBM) WHO grade IV (histologically confirmed by a pathologist)
- •· Progression during or within 6 months after last temozolomide treatment
- •· Time since last temozolomide > 21 days
- •· Prior external beam radiotherapy (54 to 62 Gy), no option for subsequent radiotherapy
- •· No clinical and radiological signs of intracerebral inflammation (in pre-study MRI not older than 4 weeks)
- •· Patients > 18 years of age.
- •· ECOG performance status of = 2 (stable over 4 weeks prior to study entrance)
- •· Female patients of childbearing potential with a negative pregnancy test within 7 days of initiation of study treatment. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- •· Male and female patients of reproductive potential who agree to employ an effective method of birth control throughout the study and for up to 6 months following discontinuation of study drug.*
- •· Signed informed consent prior to initiation of any study procedure
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •· Female patients who are pregnant or breast-feeding
- •· History of severe hypersensitivity reaction (=grade 3) to any component of the investigational drugs or excipients (allergy to or other intolerability of gadolinium, docetaxel, cabazitaxel or polysorbate 80 containing drugs)
- •· Unable to undergo Gd-MRI
- •· Time since external beam radiotherapy <12 weeks
- •· Patients who have been treated with any investigational agent(s) within 28 days of the first day of administration of study drug.
- •· Current active second malignancy other than non-melanoma skin cancers and post-treatment of localized prostate cancer. Patients are not considered to have a currently active malignancy if they are in complete remission for > 3 years prior to study
- •· Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- •· Known HIV infection, active Hepatitis B or C infection
- •· Any serious and/or unstable pre-existing psychiatric or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
- •· Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity (except alopecia) and delayed hematological recovery following last temozolomide cycle
- •· Additional anti-cancer treatment for GBM other than study drug and supportive measures (i.e. dexamethason)
- •· Inadequate organ and bone marrow function as evidenced by:
- •a) Hemoglobin <9.0 g/dL
- •b) Absolute neutrophil count <1.5 x 109/L,
- •c) Platelet count <100 x 109/L,
- •d) AST/SGOT and/or ALT/SGPT >2.5 x ULN;
- •e) Total bilirubin >1.0 x ULN,
- •f) Serum creatinine >1.5 x ULN.
- •If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated
- •according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded
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