UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024327 |
|---|---|
| Receipt number | 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 | 2021/08/05 22:46:57 |
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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
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
fukuhara-tatsuro@miyagi-pho.jp
Sponsor or person
Institute
Miyagi Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027781
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
