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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031182
Receipt No. 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

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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
Email 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
Email yutaro1008@hotmail.co.jp

Sponsor
Institute Showa University institute of molecular oncology
Showa University School of Medicine, Division of Medical Oncology, Department of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032177

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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