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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000510
Receipt No. R000000618
Scientific Title A genotype directed dose-finding study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with advanced metastatic colorectal cancer and gastric cancer.
Date of disclosure of the study information 2006/11/01
Last modified on 2008/12/11

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Basic information
Public title A genotype directed dose-finding study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with advanced metastatic colorectal cancer and gastric cancer.
Acronym UGT1A1 polymorphisms genotype-directed dose finding trial of Irinotecan(CPT-11) for gastrointestinal cancer.
Scientific Title A genotype directed dose-finding study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with advanced metastatic colorectal cancer and gastric cancer.
Scientific Title:Acronym UGT1A1 polymorphisms genotype-directed dose finding trial of Irinotecan(CPT-11) for gastrointestinal cancer.
Region
Japan

Condition
Condition colorectal cancer/ gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To estimate safety profile for bi-weekly Irinotecan monotherapy by the groups of UGT1A1 gene polymorhisms in patients with metastatic colorectal cancer and advanced gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Maximum tolerated dose for the heterozygous group and the homozygous group, respectively. Incidence rate of dose limiting toxicities for the wild group.
Key secondary outcomes Recommended dose and dose limiting toxicity for heterozygous group and the homozygous groups, respectively. Incidence grade and frequency of toxicity. Pharmacokinetics of CPT-11, APC, SN-38 and SN-38G. Genetic polymorphisms analysis of UGT1A1,UGT1A7,UGT1A9 and OATP1B1 related to PK of CPT-11 and metabolites.

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 Administraion of CPT-11 is twice for 4 weeks on days 1 and 15. CPT-11 is reconstituted in >=250 mL of normal saline or 5% dextrose in water and infuse 90min on day 1 for pharmacokinetics, and 90min over on day15. CPT-11 adjusted dosage is determined from 50,75,100,125 or 150mg/sqm in the heterozygous group and the homozygous group by continual reassessment method. CPT-11 dosage is fixed at 150mg/sqm in the wild group.Definision of UGT1A1 polymorphisms groups: The homozygous group is patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6. The heterozygous group is patient with heterozygous genotype of either UGT1A1*28 or UGT1A1*6. The wild group is patients with no UGT1A1*28 and UGT1A1*6 mutation.
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 and gastric cancer
2)Metastatic colorectal cancer and locally advanced and/or metastatic gastric cancer
3)Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms
4)Having prior chemotherapy as standard regimens
5)Wash out:>=14 days for operation, and >=21 days for chemotherapy and/or radiotherapy
6)No prior irinotecan containing treatment
7)Age:>=20 years old at wiritten informed concent
8)PS(ECOG):0 to 1
9)A life expectancy for at least 2 months
10)Aduquate main organ (bone marrow, heart, pulumonary, liver, renal) function
(1)WBC 3,000-12,000/mm^3,(2)Neutrophil >=1500/mm^3,(3)Hb >=8.5mg/dL,(4)Platelet >=100,000/mm^3,(5)AST <=100IU/L,(6)ALT <=100IU/L,(7)T-bilirubin <=2.0mg/dL,(8)serum creatinine <=1.50mg/dL
11)Written informed consent
Key exclusion criteria 1)History of serious drug allergy
2)Active concomitant malignancy
3)Prior extensively irradiation for abdominal or bowel bone marrow
4)Symptomatic brain metastasis
5)Systemic continual use of steroids
6)Active infection
7)Persistent diarrhea (watery stool)
8)Intestinal obstraction or paralytic ileus
9)Interstitial pneumonia or pulmonary fibrosis
10)Massive pleural, pericardial effusion or asites that required drainage
11)Need to treatment with atazanavir sulfate
12)Uncontrolled diabetes mellitus
13)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment
14)Psychological disease deemed to unacceptable for inclusion to the study
15)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy
16)Other concominant medical condition deemed to inadequate for inclusion to the study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuh Sakata
Organization Misawa City Hospital
Division name Internal medicine
Zip code
Address 1-10,Chuomachi 4-chome, Misawa City, Aomori,033-0051 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Sugimoto
Organization Yakult Honsha Co.,Ltd
Division name Post Marketing Development, Pharmaceutical Department Department
Zip code
Address 3F Ginza-Kobiki Bldg.,16-21,Ginza 7-chome, Chuo-ku, Tokyo,104-0061 JAPAN
TEL
Homepage URL
Email shinji-sugimoto@yakult.co.jp

Sponsor
Institute Yakult Honsha Co.,Ltd
Institute
Department

Funding Source
Organization Yakult Honsha Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
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
2006 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2006 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 10 Month 31 Day
Last modified on
2008 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000618

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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