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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010520
Receipt No. 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

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Basic information
Public title A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
Acronym A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy (AX-BC)
Scientific Title A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
Scientific Title:Acronym A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy (AX-BC)
Region
Japan

Condition
Condition Unresectable or recurrent bilary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes toxicity, objective response rate, overall survival and biomarkers at the baseline

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of axitinib
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Furuse
Organization Kyorin University, School of Medicine
Division name Department of Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akiyoshi Kasuga
Organization Kyorin University, School of Medicine
Division name Department of Medical Oncology
Zip code
Address
TEL
Homepage URL
Email akiyoshi_81@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University, School of Medicine
Institute
Department

Funding Source
Organization Kyorin University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital, National Cancer Center Hospital East, Cancer Institute Hospital, Graduate School of Medicine, University of Tokyo, Kanagawa Cancer Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 17 Day
Last modified on
2013 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.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


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