UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026409 |
|---|---|
| Receipt number | R000030342 |
| Scientific Title | The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2017/03/05 |
| Last modified on | 2018/10/06 15:54:45 |
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Basic information
Public title
The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer
Acronym
The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer
Scientific Title
The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer
Scientific Title:Acronym
The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the relationship between pharmacokinetics of gefitinib and genetic polymorphisms of metabolic enzymes and transporters
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To elucidate the pharmacokinetic factors relating gefitinib-induced toxicity
Key secondary outcomes
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
Gefitinib
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 or cytologically confirmed non-small cell lung cancer
2) Positive for EGFR sensitive mutation
3) Unresectable advanced or recurrent disease
4) Age is over 20 years.
5) Performance status (ECOG) is 0 to 2
6) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy
Absolute neutrophil count>1,500/mm3
Platelet count>100,000/mm3
Hemoglobin>8.0g/dL
AST and ALT<2.5 times the upper limit of normal(ULN)
Total bilirubin<2.0mg/dL
7) Signed, written informed concent is obtained
Key exclusion criteria
1) Interstitial pneumonia, pulmonary fibrosis
2) Severe active infection
3) Serological positive for HBs-antigen or HCV-antibody
4) Previous therapy with pazopanib
5) Unstable angina or myocardial infarction within 3 months
6) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease)
7) Active synchronous cancer
8) Severe psychiatric disorder
9) Pregnant or lactating women, or men and women without wanting pregnancy
10) Severe hypersensitivity to medicine
11) Taking medicines affecting CYP3A4 within one week before starting gefitinib therapy (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, ketokonazole, macrolide)
12) Taking proton pump inhibitor or H2 blocker within one week before starting gefitinib therapy
13) Patients who were judged inappropriate for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroo Ishida |
Organization
Showa University School of Medicine
Division name
Division of Medical Oncology, Department of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
hishida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroo Ishida |
Organization
Showa University School of Medicine
Division name
Division of Medical Oncology, Department of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
Homepage URL
hishida@med.showa-u.ac.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
Other
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
| 2017 | Year | 03 | Month | 05 | 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
| 2013 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 05 | Day |
Last modified on
| 2018 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030342
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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