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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032725
Receipt No. R000037313
Scientific Title A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer
Date of disclosure of the study information 2018/05/25
Last modified on 2019/05/26

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Basic information
Public title A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer
Acronym Study of Pharmacokinetics and Pharmacogenetics of Regorafenib
Scientific Title A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal Cancer
Scientific Title:Acronym Study of Pharmacokinetics and Pharmacogenetics of Regorafenib
Region
Japan

Condition
Condition Metastatic Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to identify high risk patients who are more likely to have severe toxicity by evaluating the association among PK, SNPs, and Regorafenib-related severe toxicity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint was to evaluate the association between SNPs of UGT1A9 and hand foot syndrome Grade 3.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria are mainly as follows (regardless of gender):
1. Has adenocarcinoma of the colon or rectum
2. Metastatic colorectal cancer
3. ECOG performance status of 0-1
4. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (refractory or intolerant to standard chemotherapy with FUs, L-OHP, CPT-11, bevacizumab as anti-VEGF antibody and cetuximab/patitumumab as anti-EGFR antibody)
5. Is able to take medications orally
6. Survival for at least 12 weeks is expected.
7. On the basis of tests carried out within 14 days before enrollment, which may be on the same day of the week as the enrollment date but 2 weeks earlier, the principal organ functions are maintained, as defined by the following criteria:
a) Neurtophils>or=1500/mm3
b) Platelets>or=75,000/mm3
c) Hemoglobin>or=8.0g/dl
d) GOT(AST)=or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis)
e) GPT(ALT) =or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis)
f) Total bilirubin =or<upper limit of normal (ULN)*1.5
g) Serum creatinine =or<upper limit of normal (ULN)*1.5
8. Has provided written informed consent
Key exclusion criteria The exclusion criteria are mainly as follows (regardless of gender):
1. Has synchronous multiple primary cancer within 5 years (except for carcinoma in situ )
2.Taking CYP3A4 inhibitors or inducers(eg, phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole, macrolide antibiotics).
3. Has complication as follows
a) poorly controlled diabetes
b) uncontrolled hypertensions
c) cirrhosis, liver failure, renal insufficiency
d) intestinal paralysis, ileus
e) interstitial lung disease, pulmonary fibrosis, emphysema
f) active infection
g) cardiac disease
h) cerebrovascular disorder, brain metastasis
i) hemorrhagic ulcer
J) psychiatric disorder
4. Is a pregnant or lactating female
5. Amalgamation of mental disease or psychotic manifestation
6. The investigator considers not suitable for the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kensei
Middle name
Last name Yamaguchi
Organization Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name Department of Gastroenterological Chemotherapy
Zip code 135-8550
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL +81-3-3520-0111
Email kensei.yamaguchi@jfcr.or.jp

Public contact
Name of contact person
1st name Kazuo
Middle name
Last name Kobayashi
Organization Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name Department of Pharmacy
Zip code 135-8550
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL +81-3-3520-0111
Homepage URL
Email kazuo.sugita@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization institutional review board,Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Address 3-8-31 Ariake, Koto-ku, Tokyo
Tel +81-3-3520-0111
Email med.shinsa@jfcr.or.jp

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
2018 Year 05 Month 25 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 30
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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 25 Day
Date of IRB
2018 Year 05 Month 24 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2024 Year 05 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to identify high risk patients who are more likely to have severe toxicity by evaluating the association among PK, SNPs, and Regorafenib-related severe toxicity .

Management information
Registered date
2018 Year 05 Month 25 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037313

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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