UMIN-CTR Clinical Trial

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

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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 or person

Institute

Kyorin University, School of Medicine

Institute

Department

Personal name



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

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