EUCTR2012-001705-24-GR进行中（未招募）1 期
Phase II single-arm study of first line treatment with gemcitabine and pazopanib in patients with inoperable locally advanced or metastatic biliary tree cancer (cholangiocarcinoma or gallbladder carcinoma)
Hellenic Cooperative Oncology Group0 个研究点目标入组 46 人开始时间: 2013年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
- •2. Age = 18 years
- •3. Histologically confirmed diagnosis of inoperable, locally advanced or metastatic cholangiocarcinoma (adenocarcinoma of intrahepatic, proximal extrahepatic, distal extrahepatic, gallbladder adenocarcinoma and periampullary bile duct adenocarcinoma). During the recruitment phase of the study, it will be ensured that gallbladder Ca patients will consist no more than 25% of the total study population.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5. Measurable disease criteria per RECIST v1.1.
- •6. No prior chemotherapy or treatment with targeted therapy
- •7. Formalin-fixed paraffin-embedded tumour and whole blood/plasma samples at diagnosis/study enrollment for biomarker studies.
- •8. Adequate organ system function:
- •Absolute neutrophil count >=1.5 x 109/L, Hemoglobin >=9 g/dL, platelets >=100 x 109/L, INR <=1.2 x ULN, aPTT <=1.2 x ULN, Total bilirubin (stenting allowed) <=1.5 x ULN, ALT and AST <=2.5 X ULN, Serum creatinine <=1.5 mg/dL (133 µmol/L) Or, if >1.5 mg/dL: Calculated creatinine clearance (ClCR) >=50 mL/min, Urine Protein to Creatinine Ratio <1 Or 24-hr urine protein <1g
- •9. Female patients are allowed to participate provided they consent to avoid pregnancy throughout the course of the trial and 1 month after the last administration of the drug, if they are surgically sterilized or menopausal. All female patients of child-bearing potential must undergo a pregnancy test (serum or urine) < 2weeks prior to first administration of the drug and consent to use effective contraception throughout the course of the trial.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Prior malignancy. Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma or indolent prostate cancer are eligible (even if they are receiving anti-hormonal therapy).
- •2. Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) are asymptomatic and have no requirement for steroids or enzyme-inducing anticonvulsants (phenyntoin, carbamazepine, phenobarbital, oxcarbazepine) in the past 6 months.
- •3. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, such as active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding, inflammatory bowel disease with increased risk of perforation, or history of abdominal fistula or intra-abdominal abcess 28 days prior to study treatment initiation.
- •4. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including malabsorption syndrome, major resection of the stomach
- •5. Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
- •6. History of myocardial infarction, unstable angina, symptomatic peripheral vascular disease or Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) or cardiac angioplasty or stenting within the past 6 months
- •7. Newly-diagnosed hypertension or history of poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg].
- •8. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
- •9. Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
- •10. Evidence of active bleeding or bleeding diathesis.
- •11. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
- •12. Recent hemoptysis (= ½ teaspoon of red blood within 8 weeks of first dose of study drug).
- •13. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
- •14. Unable or unwilling to discontinue use of prohibited medications listed in Appendix C Section of the protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
- •15. Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib
- •16. Administration of any non-oncologic investigational study drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment.
- •17. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
- •18. Pregnancy or lactation. Female patients must be surgically sterilised, menopausal, or must consent to use effective contraception throughout the course of the trial. All
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