UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032725
Receipt number 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 2022/11/27 09:05:57

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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 or person

Institute

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Institute

Department

Personal name



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

Main results already published

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

2022 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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