UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037313