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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033301
Receipt No. R000037963
Scientific Title Pharmacokinetic and dose finding study of osimertinib in patients with impaired renal function and low body weight
Date of disclosure of the study information 2019/03/31
Last modified on 2019/07/06

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Basic information
Public title Pharmacokinetic and dose finding study of osimertinib in patients with impaired renal function and low body weight
Acronym Clinical pharmacology of osimertinib in patients with impaired renal function and low body weight
Scientific Title Pharmacokinetic and dose finding study of osimertinib in patients with impaired renal function and low body weight
Scientific Title:Acronym Clinical pharmacology of osimertinib in patients with impaired renal function and low body weight
Region
Japan

Condition
Condition NSCLC with EGFR mutation
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this phase 1 study is to evaluate the pharmacokinetics and safety of osimertinib in patients with varying degrees of renal function or body weight.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate recommended dose of osimertinib in patients with varying degrees of renal function or body weight.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cohort A, normal
Interventions/Control_2 Cohort B, mild renal dysfunction
Interventions/Control_3 Cohort C, low body weight
Interventions/Control_4 Cohort D, severe renal dysfunction
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. Histlogically confirmed NSCLC with EGFR mutation
2. Advanced or metastatic NSCLC
3. Patients are scheduled for treatment with osimertinib therapy.
Key exclusion criteria 1. Patients with severe concomitant disease
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Noboru
Middle name
Last name Yamamoto
Organization National Cancer Center Hospital
Division name Department of Experimental Therapeutics
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Email yutakafu@ncc.go.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Fujiwara
Organization Mitsui Memorial Hospital
Division name Department of Respiratory Medicine
Zip code 101-8643
Address Kanda-Izumicho 1, Chiyoda-ku, Tokyo
TEL 03-3862-9111
Homepage URL
Email yutakafu@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel 03-3542-2511
Email yutakafu@ncc.go.jp

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
2019 Year 03 Month 31 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
2018 Year 09 Month 01 Day
Date of IRB
2019 Year 03 Month 07 Day
Anticipated trial start date
2019 Year 03 Month 15 Day
Last follow-up date
2021 Year 03 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
2018 Year 07 Month 05 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037963

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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