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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004747
Receipt No. R000005652
Scientific Title Phase1 trial of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer
Date of disclosure of the study information 2010/12/17
Last modified on 2010/12/17

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Basic information
Public title Phase1 trial of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer
Acronym Phase1 trial of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer
Scientific Title Phase1 trial of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer
Scientific Title:Acronym Phase1 trial of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to establish the feasibility and efficacy of Panitumumab combined with S-1 and irrinotecan in advanced/metastatic colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Maximum tolerated dose
Recommended dose
Key secondary outcomes safety

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 Panitumumab:Bi-weekly administration 6 mg/kg
TS-1 is orally administered b.i.d. on days 1-14 and CPT-11 is intravenously administered on days 1,8 every 4 weeks
S-1:Level1 65mg/m2 day1-14
Level2 80mg/m2 day1-14
CPT-11:Level1,2 125mg/m2, day1
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.Histologically confirmed colorectal cancer
2.KRAS wild type
3.Patients with one or two prior chemotherapy
4.Age >=20
5.ECOG performance status 0 or 1
6.Life expectancy of more than 3 months
7.Sufficient organ functions
.WBC 3,000/mm3-12,000/mm3
.Neurtophils >=1,500/mm3
.Platelets >=100,000/mm3
.Hemoglobin >=9.0g/dl
.Total bilirubin <=1.5mg/dl
.GOT and GPT <=100IU/l
.Creatinine <1.2mg/dl
.Creatinine Crearance >=60ml/min
8.the case can eat
9.Written IC
Key exclusion criteria 1. Multiple malignancies
2. Serious complications(intestinal paralysis and intestinal obstruction, interstitial pneumonia, pulmonary fibrosis,renal failure, cardiac failure , liver failure)
3.Infection
4.Diarrhea
5. mechanical bowel obstruction
6.Uncontrolable pleural effusion or ascites requiring
7.History of serious drug hypersensitivity
8.Need to treatment with flucytosine, atazanavir sulfate
9.Fresh bleeding of digestive organs
10.Cirrhosis, Icterus
11.Evidence of psychiatric disability interfering with enrollment to clinical trial
12.Need to treatment with heart failure, ischemic heart disease or arrhythmia
13.Uncontrolable diabetes
14.Symptomatic brain metastasis
15.Pregnant or lactating women or women of childbearing potential.
16.Patients judged inappropriate for this study by physicians
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Enomoto
Organization Toho University, Ohashi Medical Center
Division name Department of Surgery
Zip code
Address 2-17-6 Ohashi Meguro-ku Tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Toho University, Ohashi Medical Center
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Toho University, Ohashi Medical Center
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

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 17 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 Open public recruiting
Date of protocol fixation
2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 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
2010 Year 12 Month 17 Day
Last modified on
2010 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005652

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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