EUCTR2014-003924-34-ES进行中（未招募）不适用
A phase II trial to assess the activity and safety of Palbociclib in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET).
Grupo Español de Tumores Neuroendocrinos (GETNE)0 个研究点开始时间: 2014年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- •1.Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of < or = 20% (well and moderately differentiated) with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
- •2.Overexpression of Cdk4 and/or phospho-Rb1 and/or cyclin D1 in tumor tissue sample from tumor biopsy or prior primary tumor resection (Molecular study will be conducted at CNIO and logistic is described later). Therefore availability of paraffin-embedding tumor tissue sample is needed.
- •3.Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
- •4.Previous treatments with chemotherapy, antiangiogenics, or interferon are permitted providing that toxicity has resolved to < grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment. Patients may be treated with somatostatin analogues during the trial. Concomitant interferon treatment is not permitted.
- •5.Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- •6.Able to swallow oral compound
- •7.Male or female, 18 years of age or older.
- •8.ECOG performance status less than 2.
- •9.Life expectancy greater than 12 weeks.
- •10.The definitions of minimum adequacy for organ function required prior to study entry are as follows. In addition, safety precautions provided in the product labeling for the anticipated control arm chemotherapy must be observed.
- •?Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ?2.5 x upper limit of normal (ULN), or AST and ALT ?5 x ULN if liver function abnormalities are due to underlying malignancy
- •?Total serum bilirubin ?1.5 x ULN
- •?Serum albumin ?3.0 g/dL
- •?Absolute neutrophil count (ANC) ?1500/?L
- •?Platelets ?100,000/?L
- •?Hemoglobin ?9.0 g/dL
- •?Creatinin clearance < 40 mL/min
- •11.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •12.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study 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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1.Prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract.
- •2.Prior treatment on Cdk4 inhibitor under clinical trial.
- •3.Creatinine clearance < 40 ml/min using Cockroft and Gault formula.
- •4.Major surgery, radiation therapy, or systemic therapy within 3 weeks of study randomization except palliative radiotherapy to non-target metastatic lesions.
- •5.Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- •6.Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken concurrently or within last 3 months prior to randomization
- •7.Prior radiation therapy to >25% of the bone marrow.
- •8.Current treatment on another clinical trial.
- •9.Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic.
- •10.Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- •11.Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
- •12.Ongoing cardiac dysrhythmias of NCI CTCAE grade ?2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
- •13.Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
- •14.Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •15.Known human immunodeficiency virus infection.
- •16.Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
- •17.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
研究者
相似试验
进行中（未招募）
1 期
A phase II trial to assess the activity and safety of TH-302 in combination with sunitinib in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) previously untreatedPatients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumours (pNET).EUCTR2014-004072-30-ESGrupo Español de Tumores Neuroendocrinos43
进行中（未招募）
1 期
A phase II trial to evaluate the safety and activity of single-agent lenalidomide given as maintenance therapy after response to second-line therapy in patients with relapsed diffuse large B cell lymphoma, not eligible for high-dose chemotherapy and autologous transplantation [Lenalidomide and DLBCL - NDpatients affected by diffused linfoma with big cellsMedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphomaEUCTR2008-003729-18-ITOSPEDALE S. RAFFAELE38
进行中（未招募）
1 期
Phase II study with Cabozantinib in patients with RET positive NSCLCAdvanced RET-rearranged non-small cell lung cancerMedDRA version: 21.1Level: LLTClassification code 10064049Term: Lung adenocarcinoma metastaticSystem Organ Class: 100000004864EUCTR2018-002948-88-ITALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA25
进行中（未招募）
1 期
A clinical trial investigating how effective and safe the combination of drugs rituximab and pembrolizumab is at treating patients with Waldenström's Macroglobulinaemia that have not responded to their initial treatment or their disease has come back after being treated.Relapsed and refractory Waldenström's MacroglobulinaemiaMedDRA version: 21.0Level: PTClassification code 10047801Term: Waldenstrom's macroglobulinaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001767-23-GBniversity College London42
招募中
不适用
A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosisNeurological - Multiple sclerosisMultiple SclerosisACTRN12622000064707niversity of Tasmania108