UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031182 |
|---|---|
| Receipt number | R000032177 |
| Scientific Title | Effects of rabeprazole on pharmacokinetics of capecitabine. |
| Date of disclosure of the study information | 2018/02/08 |
| Last modified on | 2018/02/07 10:44:32 |
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Basic information
Public title
Effects of rabeprazole on pharmacokinetics of capecitabine.
Acronym
Drug-drug interaction between capecitabine and rabeprazole.
Scientific Title
Effects of rabeprazole on pharmacokinetics of capecitabine.
Scientific Title:Acronym
Drug-drug interaction between capecitabine and rabeprazole.
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Recent research have showm that coadministration of proton pump inhibitor (PPI) could reduce the efficacy of capecitabine. However,underlying mechanisms of the interaction between capecitabine and PPI ramain unclear. One possibility is the alteration of capecitabine pharmacokinetics by the coadministration of rabeprazole. This prospective study analyzes the effects of rabeplazole on the pharmacokinetics of capecitabine and its active metabolites.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate Effects of rabeprazole on pharmacokinetics of capecitabine.
Key secondary outcomes
(1) To investigate association with the genetic polymorphism and the pharmacokinetics.
(2) To investigate efficacy and toxicity of capecitabine in combination with PPIs.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who take PPIs before the study are assigned to rabeprazole arm.
Interventions/Control_2
Patients who do not take PPIs before the study are assigned to control arm.
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)CapeOX and CapeOX+ Bevacizumab for metastatic colorectal cancer, CapeOX as adjuvant chemotherapy for colon cancer.
2)No history of chemotherapy within 2 weeks.
3)Eastern Cooperative Oncology Group (ECOG)performance status (PS) 0 or 1.
4)Patients with at least 3 months of life-expectancy.
5)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy.
1.Absolute neutrophil count >= 1,500/mm3
2.Platelet count >= 75,000/mm3
3.Hemoglobin >= 9.0g/dL
4.AST and ALT <= 2 times the upper limit of normal(ULN) (<= 5 times the ULN if liver metastases are present)
5.ALP <= 2.5 times the upper limit of normal(ULN) (<= 5 times the ULN if liver metastases are present)
6.Creatinine clearance 51 mL/min or higher. (Cockcroft-Gault equation)
6)Signed, written informed concent is obtained.
Key exclusion criteria
1)Interstitial pneumonia, pulmonary fibrosis.
2)Ongoing severe infection.
3)Prior treatment with capecitabine.
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 Carboxylesterase inducers.
11)Patients who are not appropriate to participate in the study safely.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaro Kubota |
Organization
Showa University School of Medicine
Division name
Department of internal medicine, Division of 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
Department of internal medicine, Division of 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 institute of molecular oncology
Showa University School of Medicine, Division of Medical Oncology, Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University institute of molecular oncology
Showa University School of Medicine, Division of Medical Oncology, Department 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
昭和大学病院 (東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 08 | 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
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | 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
Management information
Registered date
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032177
