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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR GILOTRIF

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Clinical Trials for Gilotrif

Trial ID Title Status Sponsor Phase Summary
NCT01783587 Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer Recruiting National Comprehensive Cancer Network Phase 1 This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause. Afatinib has been studied in other clinical trials of participants with head and neck cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research studies. This is the first clinical trial to study Afatinib in combination with Radiation Therapy. The purpose of this study is to determine the safest dose of Afatinib when given in combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy for head and neck cancer. Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by blocking multiple proteins known to play a role in the growth of cancer cells. Information from laboratory research studies suggests that this drug may help to make head and neck cancer cells more sensitive to Radiation Therapy. The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the standard treatment if you have high risk disease. "High risk disease" means that without additional therapy, there is a high risk that the disease may return. In this study, participants with high-risk disease will receive Radiation Therapy and Docetaxel and Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may return. Radiation Therapy alone is the standard treatment approach for intermediate risk cancer. In this study, participants with intermediate risk disease will receive Radiation Therapy and Afatinib.
NCT01783587 Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer Recruiting Dana-Farber Cancer Institute Phase 1 This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause. Afatinib has been studied in other clinical trials of participants with head and neck cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research studies. This is the first clinical trial to study Afatinib in combination with Radiation Therapy. The purpose of this study is to determine the safest dose of Afatinib when given in combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy for head and neck cancer. Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by blocking multiple proteins known to play a role in the growth of cancer cells. Information from laboratory research studies suggests that this drug may help to make head and neck cancer cells more sensitive to Radiation Therapy. The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the standard treatment if you have high risk disease. "High risk disease" means that without additional therapy, there is a high risk that the disease may return. In this study, participants with high-risk disease will receive Radiation Therapy and Docetaxel and Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may return. Radiation Therapy alone is the standard treatment approach for intermediate risk cancer. In this study, participants with intermediate risk disease will receive Radiation Therapy and Afatinib.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gilotrif

Condition Name

Condition Name for Gilotrif
Intervention Trials
Non-small Cell Lung Cancer 2
Stage IV Non-Small Cell Lung Cancer 2
Recurrent Non-Small Cell Lung Carcinoma 2
Squamous Cell Carcinoma of the Head and Neck 1
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Condition MeSH

Condition MeSH for Gilotrif
Intervention Trials
Lung Neoplasms 6
Carcinoma, Non-Small-Cell Lung 5
Carcinoma 4
Carcinoma, Squamous Cell 3
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Clinical Trial Locations for Gilotrif

Trials by Country

Trials by Country for Gilotrif
Location Trials
United States 40
Hong Kong 1
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Trials by US State

Trials by US State for Gilotrif
Location Trials
California 4
Tennessee 3
Indiana 2
Illinois 2
New York 2
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Clinical Trial Progress for Gilotrif

Clinical Trial Phase

Clinical Trial Phase for Gilotrif
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 6
Phase 1 6
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Clinical Trial Status

Clinical Trial Status for Gilotrif
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 2
Completed 2
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Clinical Trial Sponsors for Gilotrif

Sponsor Name

Sponsor Name for Gilotrif
Sponsor Trials
National Cancer Institute (NCI) 4
Boehringer Ingelheim 4
National Comprehensive Cancer Network 2
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Sponsor Type

Sponsor Type for Gilotrif
Sponsor Trials
Other 15
Industry 6
NIH 4
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