UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023014 |
|---|---|
| Receipt number | R000026514 |
| Scientific Title | A study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy |
| Date of disclosure of the study information | 2016/07/04 |
| Last modified on | 2021/05/18 10:56:09 |
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Basic information
Public title
A study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
Acronym
AX-BC study
Scientific Title
A study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy
Scientific Title:Acronym
AX-BC study
Region
| Japan |
Condition
Condition
Unresectable or recurrent biliary 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) Progressive disease under gemcitabine-based chemotherapy or discontinuation of gemcitabine-based chemotherapy due to adverse events
5) Sufficient oral intake
6) Evidence of unidimensionally measurable disease
7) Without CNS metastasis
8) Without moderate or more ascites/pleural effusion
9) Life expectancy of 12 weeks or more
10) More than 2 weeks between the last administration of the prior chemotherapy regimen and study entry
11) 20 or more years of age
12) Eastern Cooperative Oncology Group performance status 0-1
13) Tumor specimens are available for biomaker analysis
14) No evidence of preexisting uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible
15) Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment
16) Adequate organ function
17) Written informed consent
18) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Key exclusion criteria
1) Simultaneous or metachronous (within 2 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2) 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
- Poor oral intake
- Need intravenous nutrition
- Malabsorption syndorome
- After total gastrectomy
- Active bleeding or past bleeding from gastrointestinal tract
- Gastrointestinal involvement of cancer
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 | Junji |
| Middle name | |
| Last name | Furuse |
Organization
Kyorin University, School of Medicine
Division name
Department of Medical Oncology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
TEL
0422-47-5511
jfuruse@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Okano |
Organization
Kyorin University, School of Medicine
Division name
Department of Medical Oncology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
TEL
0422-47-5511
Homepage URL
naohiro-okano@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kyorin University Faculty of Medicine, IRB
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
Tel
0422-47-5511
irb@ks.kyorin-u.ac.jp
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
| 2016 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://theoncologist.onlinelibrary.wiley.com/doi/10.1002/onco.13547
Number of participants that the trial has enrolled
19
Results
Median PFS: 2.8 months
Median OS: 5.8 months
Response rate: 5.3%
Results date posted
| 2021 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026514
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