NL-OMON50409已完成不适用
A clinical phase I, open-label PET study with 89Zr CriPec docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of 89 Zr CriPec docetaxel - PICCOLO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age older or equal to 18 years
- •2. A pathologically confirmed diagnosis of advanced, recurrent and progressive
- •cancer that is refractory to standard therapy or for which no standard therapy
- •exists and where treatment with a taxane is an appropriate treatment option
- •3. Measurable or evaluable disease according to RECIST criteria v.1.1. Patient
- •must have at least one measurable lesion with a long axis diameter of > 2 cm.
- •4. Performance status (WHO scale/ECOG) smaller or equal than 2
- •5. Estimated life expectancy of at least 12 weeks
- •6. Toxicities incurred as a result of previous anti-cancer therapy (radiation
- •therapy, chemotherapy, or surgery) must be resolved to * grade 2 (as defined by
- •CTCAE version 4.0)
- •7. ANC equal or> 1.5 x 109/L; platelets equal or > 100 x 109/L; Haemoglobin
- •equal or >* 6.0 mmol/L ( equal or >* 9.6 g/dL)
- •8. Creatinine ** 1.5 x upper limit of normal (ULN); or creatinine clearance
- •equal or > 60 mL/min (Cockcroft-Gault)
- •9. Serum bilirubin ** 1.5 x ULN; alkaline phosphatase, ASAT and ALAT ** 2.5 x
- •ULN, unless related to liver metastases, in which case ** 5 x ULN is allowed
- •10. Written informed consent according to local guidelines
排除标准
- •* Less than 4 weeks since the last treatment with other anti-cancer therapies,
- •(i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc.), less
- •than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas
- •and mitomycin C prior to first study treatment
- •* A history of grade 2 or higher skin toxicity as a result of prior treatment
- •with taxanes
- •* If excessive sequestering of 89Zr CriPec ® docetaxel in healthy liver is
- •observed in the first 3 patients, patients with only liver lesion will not be
- •* Current or recent (within 28 days of first study treatment) treatment with
- •another investigational drug or participation in another investigational study
- •* Current malignancies at other sites, with exception of adequately treated
- •cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell
- •carcinoma of the skin
- •* Major surgical procedure (including open biopsy, excluding central line IV
- •and port-a-cath) within 28 days prior to the first study treatment, or
- •anticipation of the need for major surgery during the course of the study
- •* Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100mm Hg)
- •* Grade *2 motor or sensory neuropathy symptoms (as defined by CTCAE version
- •* Known hypersensitivity to any of the study drugs or excipients or taxanes
- •* Any active skin condition associated with impaired skin integrity exposing
- •the patient at risk to develop skin toxicity
- •* Clinically significant (i.e. active) cardiovascular disease defined as:
- •* Stroke within * 6 months prior to first study treatment;
- •* Transient Ischemic Attack (TIA) within * 6 months prior to first study
- •* Myocardial infarction within * 6 months prior to first study treatment;
- •* Unstable angina;
- •* New York Heart Association (NYHA) Grade II or greater Congestive Heart
- •Failure (CHF);
- •* Serious cardiac arrhythmia requiring medication;
- •* Clinically relevant pathologic findings in electrocardiogram (ECG);
- •* Left Ventricle Ejection Fraction (LVEF) by MUGA or ECHO < 50%
- •13. Patients who are pregnant or breastfeeding
- •14. Absence of effective means of contraception as of Run-in Day 1 in female
- •patients of childbearing potential (defined as <2 years after last menstruation
- •and not surgically sterile) or in male patients who are not surgically sterile
- •and who have female partners of childbearing potential
- •15. Evidence of any other medical conditions (such as psychiatric illness,
- •infectious diseases, drug or alcohol abuse, physical examination or laboratory
- •findings) that may interfere with the planned treatment, affect patient
- •compliance or place the patient at high risk from treatment-related
- •complications
研究者
相似试验
尚未招募
2 期
A phase II, open label, multi-center study of 89Zr-DF-Crefmirlimab for CD8 positron emission tomography in patients with locally advanced or metastatic solid tumourslocally advanced or metastatic solid tumors10027656NL-OMON56589niversitair Medisch Centrum Groningen16
Unknown
不适用
Safety Study of 89Zr-NY001 PET Imaging in PatientsSolid Tumor, AdultNCT04971369Wuxi No. 4 People's Hospital20
已完成
不适用
A Phase I Study to Assess Biodistribution of 89Zr-CB307 in PSMA+ and PSMA-Tumour LesionsNL-OMON51775Cresendo Biologics Ltd12
暂停
1 期
Zr-89 Cimzia PET Imaging Rheumatoid ArthritisRheumatoid ArthritisNCT03546335Robert Flavell, MD, PhD10
已完成
不适用
89Zr-pembrolizumab-PET imaging in patients with locally advanced or metastatic melanoma or non-small cell lung cancerMelanoma and non-small cell lung cancer1004090010029107NL-OMON43013niversitair Medisch Centrum Groningen21