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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006047
Receipt No. R000004626
Scientific Title Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Date of disclosure of the study information 2011/09/01
Last modified on 2014/02/07

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Basic information
Public title Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Acronym Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Scientific Title Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Scientific Title:Acronym Panitumumab monotherapy for gemcitabine, TS-1 and CDDP tolerant or failure unresectable or recurrent cholangiocarcinoma, evaluation of safety and efficiency
Region
Japan

Condition
Condition cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of 3rd-line Panitumumab for gemcitabin, TS-1, CDDP tolerant unresectable or recurrent cholangiocarcinoma
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes response rate (CR+PR)
Key secondary outcomes Severe adverse events
Progression free survival (PFS)
Time to progression (TTP)
Overall survival (OS)
Median survival time (MST)
Disease control rate (DCR)
adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Biweekly administration of Panitumumab (6mg/kg, div, over 1hr), evaluation of adverse effect grade with NCI-CTC ver.4 and its frequency. administration is continued untill tumor progression is detected (RECIST ver. 3.1).
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)Refractory to prior both gemcitabine, TS-1 and CDDP based chemotherapy
(4)Measurable disease as defined by Revised RECIST guideline (version 1.1)
(5)ECOG PS of 0 or 1
(6)No severe organ function impairment
(7)Life expectancy > 3 months
(8)Sufficient oral intake
(9)Written informed consent
(10)Aged over 20 with judgment

Key exclusion criteria (1)Previous history of chemotherapy with anti-EGFR antibody
(2)Tumor is controllable with any other therapy (SD, PR, CR, NE in RECIST ver.1.1)
(3)Previous history of infusion reaction by antibody drug
(4)Serious complications (e.g. severe hypertension, severe heart failure, severe coronary artery disease, myocardial infarction within 3 months, severe hepatic failure, poorly controlled diabetes, plumonary fibrosis, interstitial pneumonia or renal failure with dialysis)
(5) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
(6)Pregnant or lactating women or women of childbearing potential (restrict lactating within 8 weeks after last Panitmumab administration)
(7)Patient with severe drug allergy
(8)Psychosis or severe mental disorder
(9)Inadequate physical condition, as diagnosed by primary physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Hayashi
Organization Tohoku University Hospital
Division name Hepato-Biliary Pancreatic Surgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL 022-717-7205
Email hiroki@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hayashi
Organization Tohoku University Hospital
Division name Hepato-Biliary Pancreatic Surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7205
Homepage URL
Email hiroki@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of Hepato-Biliary Pancreatic Surgery
, Tohoku University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 01 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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 09 Month 01 Day
Date trial data considered complete
2016 Year 09 Month 01 Day
Date analysis concluded
2017 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 26 Day
Last modified on
2014 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004626

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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