UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000510 |
|---|---|
| Receipt number | 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 16:32:25 |
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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
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
shinji-sugimoto@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co.,Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000618
