EUCTR2013-001949-13-GB进行中（未招募）不适用
An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease - InterAACT A Multicentre Randomised Phase II Advanced Anal Cancer Trial
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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 verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus.
- •2.Age =18 years.
- •3.ECOG PS =2.
- •4.Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.
- •5.Previous definitive chemo-radiation is permitted for early stage squamous cell carcinoma of the anus.
- •6.HIV+ patients will be considered eligible with a CD4 count of =200.
- •7.Adequate cardiac and respiratory function; absolute neutrophil count (ANC) =1.5x109/l; white blood cell (WBC) count =3x109/l; platelets =100x109/l; haemoglobin (Hb) =9g/dl; creatinine clearance =50ml/minute; serum bilirubin =1.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) =2.5x ULN; alkaline phosphatase (ALP) =3x ULN.
- •8.Life expectancy of at least 3 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are
- •2.Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus.
- •3.Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- •4.Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- •5.Surgery or palliative radiotherapy within 28 days of randomisation.
- •6.Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure.
- •7.History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
- •8.Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).
- •9.Acute hepatitis C and/or chronic active hepatitis B infection.
- •10.Serious active infection requiring i.v. antibiotics at enrolment.
- •11.Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- •12.Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.
- •13.Known hypersensitivity to any of the study drugs or excipients.
- •14.Pregnant or lactating females.
研究者
相似试验
进行中（未招募）
不适用
An international multicentre clinical trial comparing two chemotherapy regimens in patients with advanced anal cancerInoperable, locally recurrent or metastatic squamous cell carcinoma of the anusMedDRA version: 16.1Level: LLTClassification code 10041815Term: Sq cell Ca anusSystem Organ Class: 100000004864EUCTR2013-001949-13-NORoyal Marsden NHS Foundation Trust80
已完成
2 期
A clinical trial to study the effects of two drugs, ozarelix and goserelin in men with prostate cancerCTRI/2010/091/006141Spectrum PharmaceuticalsInc102
进行中（未招募）
1 期
Clinical Study assessing TAS-114 in Combination with S-1 in Patients withAdvanced or Metastatic Non-Small Cell Lung CancerMale and female patients age 18 years or older with histologically or cytologically confirmed advanced or metastatic NSCLC for whom standard therapy no longer existsMedDRA version: 19.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001806-40-ESTaiho Oncology, Inc.124
进行中（未招募）
1 期
Clinical Study assessing TAS-114 in Combination with S-1 in Patients withAdvanced or Metastatic Non-Small Cell Lung CancerEUCTR2016-001806-40-PLTaiho Oncology, Inc.124
进行中（未招募）
1 期
A study to compare the study drug IMMU-132 with standard treatments in Metastatic Triple-Negative Breast Cancer patients Who have Received at Least Two Prior Treatments.Relapsed/Refractory Triple-Negative Breast CancerMedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-003019-21-ESImmunomedics, Inc.328