A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
- Conditions
- nresectable or recurrent bilary tract cancer
- Registration Number
- JPRN-UMIN000010520
- Lead Sponsor
- Kyorin University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Not provided
1) Simultaneous or metachronous (within 2 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Active hemorrhagic ulcer or active diverticulitis 3) Major surgery <4 weeks of starting the study treatment 4) Radiation therapy <2 weeks of starting the study treatment 5) A serious gastrointestinal disorder that would impair their ability to receive study treatment. 6) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 7) Psychosis or severe mental disorder 8) Complications such as myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism, within the 12 months prior to study drug administration 9) Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis 10) Active infection except hepatitis B or C virus 11) Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness 12) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, uncontrollable diabetes millitus etc 13) Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors 14) Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers 15) Requirement of anticoagulant therapy with oral vitamin K antagonists 16) Patients who can't receive neither iodic drug nor gadolinium because of drug allergy 17) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method toxicity, objective response rate, overall survival and biomarkers at the baseline