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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024327
Receipt No. R000027781
Scientific Title An observational study of serum and cerebrospinal fluid concentrations of osimertinib for the treatment of lung cancer harboring EGFR activating and T790M mutations.
Date of disclosure of the study information 2016/10/17
Last modified on 2018/04/09

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Basic information
Public title An observational study of serum and cerebrospinal fluid concentrations of osimertinib for the treatment of lung cancer harboring EGFR activating and T790M mutations.
Acronym An observational study of serum and cerebrospinal fluid concentrations of osimertinib.
Scientific Title An observational study of serum and cerebrospinal fluid concentrations of osimertinib for the treatment of lung cancer harboring EGFR activating and T790M mutations.
Scientific Title:Acronym An observational study of serum and cerebrospinal fluid concentrations of osimertinib.
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the relationship of serum osimertinib concentration and efficacy/toxicity.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the relationship of serum osimertinib concentration and toxicity
Key secondary outcomes 1)To evaluate the relationship of serum osimertinib concentration and efficacy.
2)To evaluate the relationships of CSF concentration of osimertinib and CNS toxicity.
3)To cleat the pharmacogenomics of osimertinib.

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 or cytologically documented non-small cell lung cancer.
2. Stage IIIB or stage IV or recurrent NSCLC.
3. Detected EGFR activating mutation (exon 19 deletion or exon 21 L858R) by highly sensitive PCR methods.
4. Have a history of first or second generation EGFR-TKI treatment.
5. Detected T790M mutation by highly sensitive PCR methods.
6. Patients who have at least one or more measurable lesion by RESIST (Version1.1)
7. Performance status (ECOG) 0-2
8. Estimated life expectancy at least 3 months.
9. Adequate organ function for osimertinib treatment
10. Written informed concent.
11. Aged over 20 years.
Key exclusion criteria 1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray.
2. With severe complication.
1)Uncontrollable angina pectoris, myocardial infarction, or heart failure.
2)Uncontrollable diabetes or hypertension.
3)Severe infectious disease.
4)gastrointestinal dysfunction with severe diarrhea.
3. Impossible to take drugs orally.
4. Inadequate case considered from drug package insert of osimertinib.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Maemondo
Organization Miyagi Cancer Center
Division name Department of respiratory medicine
Zip code
Address 47-1 Nodayama, Medecshima-Shiote, Natori, Japan
TEL 022-384-3151
Email maemondo-ma693@miyagi-pho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Fukuhara
Organization Miyagi Cancer Center
Division name Department of respiratory medicine
Zip code
Address 47-1 Nodayama, Medecshima-Shiote, Natori, Japan
TEL 022-384-3151
Homepage URL
Email fukuhara-tatsuro@miyagi-pho.jp

Sponsor
Institute Miyagi Cancer Center
Institute
Department

Funding Source
Organization Miyagi Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of thoracic oncology, Akita University.
Department of Palliative medicine, Tohoku University.
Department of Pharmacy, Akita University Hospital.
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 17 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Serum osimertinib concentration is measured in all registered patients. When tha case has brain metastasis and lumbar puncture for evaluation of carcinomatous meningitis is necessary, concentration in CSF is measured.

Management information
Registered date
2016 Year 10 Month 07 Day
Last modified on
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027781

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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