UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031501 |
|---|---|
| Receipt number | R000035902 |
| Scientific Title | A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib |
| Date of disclosure of the study information | 2018/03/09 |
| Last modified on | 2021/03/01 12:44:42 |
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Basic information
Public title
A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Acronym
A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Scientific Title
A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Scientific Title:Acronym
A phase I study Afatinib in Combination of Osimertinib in patients with Relapsed Non-Small Cell Lung Cancer after failure of prior Osimertinib
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine of dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) for the combination of osimertinib with afatinib for non-small cell lung cancer patients with EGFR active mutations after failure of osimertinib
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine of dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD)
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
Osimertinib 80mg day1~ + Afatinib day1~each dose cohort
Cohort1 Afatinib 20mg
Cohort2 Afatinib 30mg
Cohort3 Afatinib 40mg
until disease progression
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) Non-small cell lung cancer proven by histology and / or cytology with EGFR active mutation
2) Stage IIIB, IIIC, IV or postoperative / post chmoradiation therapy recurrence
3) prior osimertinib failure
4) patients who could treat with a 80mg dose of osimertinib
5) 20 years or older
6) performance status 0 or 1
7) Adequate organ function
8) At least one or more measurable lesion by RECIST
9) Written informed consent for translational research
10) Written informed consent
Key exclusion criteria
1) Patients who are difficult to treat enrolled doses due to toxicity of afatinib
2) History of drug-induced pneumonitis, Interstitial pneumonia
3) Symptomatic brain metastasis, leptomeningitis
4) Bone metastasis to treat by operation or radiation therapy
5) Uncontrollable pleural, peritoneal or pericardial effusion
6) Prior thoracic palliative radiotherapy within 2wks
7) SCLC transformation
8) History of active double cancer
9) Severe infection
10) Active HBV infection
11) No intention to birth control
12) Unstable psychic disorder
13) Under treatment of steroid therapy or immunosuppressive therapy
14) History of allergic reaction
15) Decision of ineligibility by a physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata Cancer Center Hospital
Division name
Department of Internal Medicine
Zip code
951-8566
Address
2-15-3, Kawagishicho, Chuo-ku, Niigata
TEL
025-266-5111
htanaka@niigata-cc.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Miura |
Organization
Niigata Cancer Center Hospital
Division name
Department of Internal Medicine
Zip code
951-8566
Address
2-15-3, Kawagishicho, Chuo-ku, Niigata
TEL
025-266-5111
Homepage URL
miusat1118@niigata-cc.jp
Sponsor or person
Institute
Niigata Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee of Wakayama MEdical University
Address
811-1, Kimiidera, Wakayama, Wakayama
Tel
073-441-0896
wa-rinrir@wakayama-med.co.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
新潟県立がんセンター新潟病院内科（新潟県）、和歌山県立医科大学内科学第3講座（和歌山県）、久留米大学医学部内科学講座、呼吸器・神経・膠原病内科部門（福岡県）、関西医科大学附属病院呼吸器腫瘍内科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 09 | 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
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | 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 | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035902
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