EUCTR2006-002877-30-IT进行中（未招募）不适用
An open label, multicenter, pilot phase II study of SOM230 s.c. in patients with duodeno-pancreatic (neuro) endocrine tumors and different pituitary diseases (Nelson?s syndrome, non-functioning adenoma, TSH-adenoma, Gonadotroph adenoma, and PRL-adenoma) with potential sensitivity to somatostatin analogues. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •Male or female patients >= 18 years ? Patients with pituitary disease or duodeno-pancreatic (neuro) endocrine tumors diagnosed with the criteria described in Table 5-1 ? Karnofsky status >60 ? Patients must have had the following washout periods: octreotide LAR - 8 weeks, octreotide s.c. - 48 hours, lanreotide (Autogel) - 8 weeks, lanreotide SR - 4 weeks. ? Written informed consent obtained prior to any screening procedures ? Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for 30 days after the study has ended. Male patients are required to use a condom throughout the study and for at least 30 days following study completion. Specific inclusion criteria by tumor type, refer to Table 5-1: ? Insulinoma ? 72 hour fast: glycopenic symptoms, low glycemia (3.3 mmol/l and inappropriately high level of insulinemia) ? Gastrinoma ? Symptoms not controlled by Proton Pump Inhibitor (PPI) and/or tumor progression. PPI could be continued throughout the study. ? PRL-adenoma ? Macroadenoma (adenoma > 10mm) not controlled by dopamine agonist. Dopamine agonist could be continued throughout study. ? Non-functioning pituitary adenoma, Gonadotroph adenoma, PRL-adenoma and Nelson?s syndrome ? Prior radiotherapy received must be at least 12 months before start of study
- •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
- •Patients with active gall bladder disease ? Poorly controlled diabetes mellitus as indicated by the presence of HbA1c > 9% (Not applicable for glucagonoma patients). ? Patients with additional active malignant diseases within the last five years (with the exception of correctly treated basal cell carcinoma or carcinoma in situ of the cervix) ? Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor?s Medical Monitor ? Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Patients who have participated in any clinical investigation with an investigational drug within 30 days prior to dosing ? Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
研究者
相似试验
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyAdult HLA-A*02-positive patients who have been diagnosed with unresectable, locally advanced and/or metastatic colorectal cancer before first-line chemotherapy. Patients must have completed a 12 week first-line oxaliplatin-based standard chemotherapy (e.g. FOLFOX or XELOX) with either complete or partial response or stable disease as the outcome.EUCTR2007-005666-12-DEimmatics biotechnologies GmbH90
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-LVimmatics biotechnologies GmbH9
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-BGimmatics biotechnologies GmbH90
进行中（未招募）
1 期
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapy - IMA910EUCTR2007-005666-12-HUimmatics biotechnologies GmbH
进行中（未招募）
不适用
An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first line treatment with oxaliplatin-based chemotherapyEUCTR2007-005666-12-BEimmatics biotechnologies GmbH90