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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000031501 |
Receipt No. | 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 | 2018/02/27 |
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 |
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Condition | ||
Condition | Non-small cell lung cancer | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Osimertinib 80mg day1~ + Afatinib day1~each dose cohort
Cohort1 Afatinib 20mg Cohort2 Afatinib 30mg Cohort3 Afatinib 40mg until disease progression |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Niigata Cancer Center Hospital | ||||||
Division name | Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 2-15-3, Kawagishicho, Chuo-ku, Niigata | ||||||
TEL | 025-266-5111 | ||||||
htanaka@niigata-cc.jp |
Public contact | |||||||
Name of contact person |
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Organization | Niigata Cancer Center Hospital | ||||||
Division name | Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 2-15-3, Kawagishicho, Chuo-ku, Niigata | ||||||
TEL | 025-266-5111 | ||||||
Homepage URL | |||||||
miusat1118@niigata-cc.jp |
Sponsor | |
Institute | Niigata Cancer Center Hospital |
Institute | |
Department |
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 | |
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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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035902 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |