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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016747
Receipt No. R000019433
Scientific Title Pharmacokinetics of Regorafenib by endogenous cortisol 6beta-hydroxylation clearance and potential of personalized use.
Date of disclosure of the study information 2015/03/09
Last modified on 2019/03/29

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Basic information
Public title Pharmacokinetics of Regorafenib by endogenous cortisol 6beta-hydroxylation clearance and potential of personalized use.
Acronym PK study of Regorafenib
Scientific Title Pharmacokinetics of Regorafenib by endogenous cortisol 6beta-hydroxylation clearance and potential of personalized use.
Scientific Title:Acronym PK study of Regorafenib
Region
Japan

Condition
Condition colorectal cancer, GIST
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To predict pharmacokinetics of regorafenib using CYP3A phenotyping method by endogenous cortisol 6-beta hydroxylation clearance, and to establish personalized use by setting of optimal dose of regorafenib based on it.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Adverse events
Key secondary outcomes OS
PFS
RR

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 Administration of regorafenib
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. Patients with histopathologically confirmed colorectal cancer or GIST.
2. Completed prior chemotherapy more than 14 days and resolved toxicity to <= Grade1.
3. Patients 20 years or older.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
5. Survival more than 3 months.
6. Adequate organ functions (listed below) are preserved within 7 days prior to initiation of study treatment.
i. Neutrophil >=1,500/mm3
ii. Hemoglobin >=9.0 g/dl
iii. Platelets >=100,000/mm3
iv. Total bilirubin <= 2.0 ml/dl
v. AST and ALT <= 100 IU/l
vi. Serum creatinine <= 1.5 mg/dl
vii. Systolic blood pressure < 150 mmHg and diastolic blood pressure < 90 mmHg.
7. Patients with written informed consent.
Key exclusion criteria 1. Uncontrolled infection(exclude hepatitis B and C ).
2. With unstable angina and cardiac infarction within 6 months.
3. With arterial or venous thrombotic or embolic events such as cerebrovascular accident, pulmonary embolism, deep vein thrombosis within 6 months.
4. Any surgical treatments within 4 weeks.
5. With a history of severe systemic diseases such as uncontrolled diabetes mellitus, cirrhosis.
6. With active multiple cancer.
7. Clinically significant mental disorder.
8. Pregnant or lactating women or women of childbearing potential.
9. Taking CYP3A4 inhibitors or inducers(eg, phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole, macrolide antibiotics). If administration is stopped even before a week of study treatment, eligible is possible.
10. patients with administration of steroids.
11. Other conditions not suitable for this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Furuse
Organization School of Medicine, Kyorin University
Division name Department of Internal Medicine, Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL 0422-47-5511
Email jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiro Okano
Organization School of Medicine, Kyorin University
Division name Department of Internal Medicine, Medical Oncology
Zip code
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL 0422-47-5511
Homepage URL
Email naohiro-okano@ks.kyorin-u.ac.jp

Sponsor
Institute School of Medicine, Kyorin University
Institute
Department

Funding Source
Organization School of Medicine, Kyorin University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo University of Pharmacy and Life Sciences
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 杏林大学医学部(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 09 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
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
2014 Year 09 Month 04 Day
Date of IRB
2014 Year 10 Month 28 Day
Anticipated trial start date
2014 Year 11 Month 17 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 09 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019433

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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