KCT0002115招募中未知
Open-label, dose-escalation, multiple dosing study to evaluate the safety, tolerability, immune response and pre efficacy of BVAC-C in patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure to standard care
Cellid0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- Female
入选标准
- •? Patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer
- •? Patients has received 1 or more platinum based doublet chemotherapy as prior therapy for progressive or recurrent tumor lesion (prior therapy does not include platinum chemotherapy given with radiation therapy for 1st line treatment before progression or recurrence)
- •? Patients with at least 1 measurable lesion according to RECIST(Response Evaluation Criteria In Solid Tumors)
- •? Female patients between ages of 20 to 70
- •? Patients with ECOG(Eastern Cooperative Oncology Group) perfomance status between 0 to 2
- •? Patients meets the blood test standards in the screening test
- •ANC(absolute neutrophil count)=1500/µL
- •LLN(lower limit of normal) =ALC(absolute neutrophil count) =ULN(upper limit of normal)
- •Platelets=100,000/µL
- •Hemoglobin> 9g/dL
- •? Patients meets the blood chemistry test standards in the screening test
- •Serum creatinine = 2.0 mg/dL
- •Calculated creatinine clearance = 50 mL/min
- •Serumbilirubin =1.5 x ULN(upper limit of normal)
- •ALT(alanine transaminase) and AST(aspartate transaminase ) =2.5 × ULN(upper limit of normal) (= 5 x ULN(upper limit of normal) in patients with liver metastases)
- •? Patients who has agreed to a medically accepted contraceptive in this clinical trial
- •? Patients at least three months or more of survival can be expected
- •? Patients decided to participate in this clinical trial and signed written informed consent
排除标准
- •? Patients histopathology is a neuroendocrine or small cell carcinoma
- •? Patients with a history of brain metastasis or signs of brain metastasis
- •? Patients tested positive in serological tests for hepatitis C virus or hepatitis B virus surface antigen , (HBsAg) or human immunodeficiency virus (HIV)
- •? Patients with a history of HIV infection
- •? Patients showing abnormal electrocardiogram , including arrhythmia
- •? Patients have been administered the drug for other clinical trials within 4weeks before the screening visit
- •? Patients have been administered any vaccines within 4weeks before the screening visit (eg. hepatitis A, hepatitis B, influenza , Td , etc. )
- •? Patients have been administered the blood products within 3 months before the screening visit
- •? Patients have received chemotherapy or radiation therapy within 4weeks before the 1st administraion of investigational drug(BVAC-C)
- •? Patients treated with immunosuppressant or immunomodulatory agents within 6 months before the screening visit
- •? Patients who have participated in the clinical trial of a therapeutic vaccine or immune therapy within 1 year before the screening visit
- •? Patients with a history of serious allergic disease or serious side effects of the drug
- •? Patients who is pregnant or breast-feeding
- •? Patients researchers has determined that participation in the clinical trial is inappropriate
- •? Patients suspected to have other primary cancer differ from cervical cancer
研究者
相似试验
进行中（未招募）
不适用
An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.Parkinson's diseaseEUCTR2006-006209-94-DEGlaxoSmithKline Research & Development Limited36
进行中（未招募）
不适用
An open label, repeat dose, dose escalation study conducted in RLS patients to characterize pharmacokinetics and food effect of ropinirole controlled release for RLSRestless Legs SyndromeMedDRA version: 8.1Level: LLTClassification code 10058920Term: Restless legs syndromeEUCTR2006-002139-26-DEGlaxoSmithKline Research & Development Limited30
进行中（未招募）
不适用
A multicentre open-label, dose-escalation, trial of zanolimumab in combination with CHOP chemotherapy in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement - Zanolimumab with CHOP in CD4+ non-cutaneous PTCL with nodal involvementEUCTR2006-004516-51-DEGenmab A/S24
进行中（未招募）
1 期
A multicentre open-label, dose-escalation, trial of zanolimumab in combination with CHOP chemotherapy in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement - Zanolimumab with CHOP in CD4+ non-cutaneous PTCL with nodal involvementCD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvementMedDRA version: 8.1Level: LLTClassification code 10034624Term: Peripheral T-cell lymphoma unspecified NOSEUCTR2006-004516-51-NLGenmab A/S24
进行中（未招募）
1 期
A research study to look at the safety, effectiveness and the effects on the body of a new drug, SBC-102, in children with growth problems caused by a deficiency in the enzyme that breaks down fatsEUCTR2011-000032-28-GBSynageva Biopharma Corp.10