UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013939 |
|---|---|
| Receipt number | R000015328 |
| Scientific Title | Clinical pharmacology study to evaluate the pharmacokinetics, safety and efficacy of multi-targetted tyrosine kinase inhibitor regorafenib in Japanese patients with advanced colorectal cancer. |
| Date of disclosure of the study information | 2014/05/12 |
| Last modified on | 2016/05/30 10:47:13 |
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Basic information
Public title
Clinical pharmacology study to evaluate the pharmacokinetics, safety and efficacy of multi-targetted tyrosine kinase inhibitor regorafenib in Japanese patients with advanced colorectal cancer.
Acronym
Clinical pharmacology study of regorafenib in Japanese patients with colorectal cancer.
Scientific Title
Clinical pharmacology study to evaluate the pharmacokinetics, safety and efficacy of multi-targetted tyrosine kinase inhibitor regorafenib in Japanese patients with advanced colorectal cancer.
Scientific Title:Acronym
Clinical pharmacology study of regorafenib in Japanese patients with colorectal cancer.
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the pharmacokinetics, safety and efficacy of regorafenib in Japanese patients with colorecral cancer.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
pharmacokinetics, progression free survival, response rate, adverse event,
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed adenocarcinoma of the colon and rectum.
2)Unresectable, locally advanced, metastatic or recurrent disease.
3)Progression after following standard therapies, which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab or panitumumab (if KRAS wild type).
4)No history of chemotherapy within 2 weeks.
5)Eastern Cooperative Oncology Group performance status of 0 to 1.
6)Measurable and evaluable disease.
7)Life expectancy of at least 3 months.
8)Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 14 days of starting to study treatment.
1.Neutrophil count 1500 /mm3 or higher.
2.Platelet count 100,000 /mm3 or higher.
3.Hemoglobin 9.0 g/dL or higher.
4.AST, ALT less than 2 times the upper limit of normal (ULN).(less than 5 times ULN for patients with liver metastasis)
5.Total bilirubin less than 1.5 times ULN.
6.ALP less than 2.5 times ULN.(less than 5 times ULN for patients with liver metastasis)
7.Serum creatinine less than 1.5 times ULN.
8.Creatinine clearance 30 mL/min or higher. (Cockcroft-Gault equation)
9)All patients were asked for written informed consent for their
peripheral blood samples and medical information to be used for
research purposes.
Key exclusion criteria
1)Known history of interstitial pneumonia or pulmonary fibrosis.
2)Ongoing severe infection.
3)Prior treatment with regorafenib.
4)Unstable angina and Myocardial infarction less than 3 months before start of study drug.
5)Patients with severe complications (incontrollable diabetes mellitus or liver cirrhosis).
6)Concurrent cancer that is distinct in primary site.
7)Psychological condition that may interfere with the patient's participation in the study.
8)Pregnant patients. Men and women who want to make baby.
9)Patients with severe drug allergy or those who had severe drug allergy in the past.
10)Concomitant use of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole and clarithromycin).
11)Concomitant use of proton pump inhibitor and histamine H2-receptor antagonist.
12)Contraindication to regorafenib.
13)Patients who are not appropriate to participate in the study safely.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutsuna Sasaki |
Organization
Showa University School of Medicine
Division name
Medical Oncology
Zip code
Address
1-5-8 Hadanodai Shinagawa-ku Tokyo
TEL
03-3784-8607
yutaro1008@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaro Kubota |
Organization
Showa University School of Medicine
Division name
Medical Oncology
Zip code
Address
1-5-8 Hadanodai Shinagawa-ku Tokyo
TEL
03-3784-8607
Homepage URL
yutaro1008@hotmail.co.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 05 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
pharmacokinetics, safety and efficacy
Management information
Registered date
| 2014 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015328
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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