UMIN-CTR Clinical Trial

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	Main results already published
Date of protocol fixation	2016 Year 09 Month 22 Day
Date of IRB	2016 Year 09 Month 22 Day
Anticipated trial start date	2016 Year 10 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

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	2021 Year 08 Month 05 Day

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