Unique ID issued by UMIN | UMIN000010520 |
---|---|
Receipt number | R000012303 |
Scientific Title | A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy |
Date of disclosure of the study information | 2013/04/18 |
Last modified on | 2013/06/29 02:42:27 |
A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy (AX-BC)
A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy (AX-BC)
Japan |
Unresectable or recurrent bilary tract cancer
Hepato-biliary-pancreatic medicine |
Malignancy
YES
To evaluate preliminary the efficacy and safety of axitinib in patients with biliary tract cancer refractory to GEM-based regimen, and to identify biomarkers that might be useful to predict the efficacy and/or toxicity of axitinib in patients with biliary tract cancer.
Safety,Efficacy
Exploratory
Phase II
Progression free survival
toxicity, objective response rate, overall survival and biomarkers at the baseline
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of axitinib
20 | years-old | <= |
Not applicable |
Male and Female
1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer
2) Recurrent or unrespectable biliary tract cancer
3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma
4) Without CNS metastasis
5) Without moderate or more ascites/pleural effusion
6) Progressive disease under gemcitabine-based chemotherapy or discontinuation of gemcitabine-based chemotherapy due to adverse events
7) Life expectancy of 12 weeks or more
8) More than 2 weeks between the last administration of the prior chemotherapy regimen and study entry
9) Evidence of unidimensionally measurable disease
10) Eastern Cooperative Oncology Group performance status 0-1
11) Sufficient oral intake
12) 20 or more years of age
13) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
14) Tumor specimens are available for biomaker analysis
15) No evidence of preexisting uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible
16) Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment
17) Adequate organ function
18) Written informed consent
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
32
1st name | |
Middle name | |
Last name | Junji Furuse |
Kyorin University, School of Medicine
Department of Medical Oncology
6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611 Japan
1st name | |
Middle name | |
Last name | Akiyoshi Kasuga |
Kyorin University, School of Medicine
Department of Medical Oncology
akiyoshi_81@ks.kyorin-u.ac.jp
Kyorin University, School of Medicine
Kyorin University, School of Medicine
Other
National Cancer Center Hospital, National Cancer Center Hospital East, Cancer Institute Hospital, Graduate School of Medicine, University of Tokyo, Kanagawa Cancer Center
NO
杏林大学医学部付属病院(東京都)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、がん研有明病院(東京都)、東京大学医学部付属病院(東京都)、神奈川県立がんセンター(神奈川県)
2013 | Year | 04 | Month | 18 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 02 | Month | 18 | Day |
2013 | Year | 04 | Month | 18 | Day |
2013 | Year | 04 | Month | 17 | Day |
2013 | Year | 06 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012303
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |