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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR AFATINIB DIMALEATE

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Clinical Trials for Afatinib Dimaleate

Trial ID Title Status Sponsor Phase Summary
NCT02122172 Afatinib in Advanced Refractory Urothelial Cancer Active, not recruiting National Cancer Institute (NCI) Phase 2 This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.
NCT02122172 Afatinib in Advanced Refractory Urothelial Cancer Active, not recruiting University of Chicago Phase 2 This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.
NCT02131259 Long-term Observation PMS for Afatinib Active, not recruiting Boehringer Ingelheim N/A In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
NCT02285361 GIOTRIF rPMS in Korean Patients With NSCLC Recruiting Boehringer Ingelheim N/A To monitor the safety profile and efficacy of GIOTRIF®(afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
NCT02364609 Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib Recruiting National Cancer Institute (NCI) Phase 1 This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given together with afatinib dimaleate in treating patients with non-small cell lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be an effective treatment for non-small cell lung cancer.
NCT02364609 Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib Recruiting University of California, Davis Phase 1 This phase I/Ib trial studies the side effects and best dose of pembrolizumab when given together with afatinib dimaleate in treating patients with non-small cell lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment, or has come back and does not respond to erlotinib hydrochloride. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and afatinib dimaleate together may be an effective treatment for non-small cell lung cancer.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Afatinib Dimaleate

Condition Name

Condition Name for Afatinib Dimaleate
Intervention Trials
Recurrent Non-Small Cell Lung Carcinoma 2
Stage IV Non-Small Cell Lung Cancer 2
Carcinoma, Non-Small-Cell Lung 2
Stage IIIB Non-Small Cell Lung Cancer 1
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Condition MeSH

Condition MeSH for Afatinib Dimaleate
Intervention Trials
Carcinoma, Non-Small-Cell Lung 4
Lung Neoplasms 2
Urinary Bladder Neoplasms 1
Urethral Neoplasms 1
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Clinical Trial Locations for Afatinib Dimaleate

Trials by Country

Trials by Country for Afatinib Dimaleate
Location Trials
United States 31
Japan 2
Korea, Republic of 1
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Trials by US State

Trials by US State for Afatinib Dimaleate
Location Trials
Indiana 2
Illinois 2
Washington 2
California 2
South Carolina 1
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Clinical Trial Progress for Afatinib Dimaleate

Clinical Trial Phase

Clinical Trial Phase for Afatinib Dimaleate
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Afatinib Dimaleate
Clinical Trial Phase Trials
Recruiting 4
Active, not recruiting 2
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Clinical Trial Sponsors for Afatinib Dimaleate

Sponsor Name

Sponsor Name for Afatinib Dimaleate
Sponsor Trials
National Cancer Institute (NCI) 4
Boehringer Ingelheim 2
University of Chicago 1
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Sponsor Type

Sponsor Type for Afatinib Dimaleate
Sponsor Trials
Other 4
NIH 4
Industry 2
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