Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
AstraZeneca
Boehringer Ingelheim
Harvard Business School
Mallinckrodt

Last Updated: October 18, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR GILOTRIF

See Plans and Pricing

« Back to Dashboard

Clinical Trials for Gilotrif

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01783587 Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer Recruiting National Comprehensive Cancer Network Phase 1 2013-02-01 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 2013-02-01 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 2013-10-01 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 2013-10-01 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.
NCT02274012 Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment Withdrawn Boehringer Ingelheim Phase 2 2014-08-01 The investigators are doing this research program to find out if the investigational drug, afatinib which is a medication known to block the function of the ErbB2 protein might help standard chemotherapy, in particular paclitaxel, work better. Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2. On July 12, 2013 the United States Food and Drug Administration (US FDA) approved afatinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors had specific EGFR gene mutations (exon 19 deletions or exon 21 i.e. L858R substitution mutations) as detected by an FDA approved test. Paclitaxel is a standard, anti-cancer medicine that has been approved by the US Food and Drug Administration (FDA) for the treatment of lung cancer. The combination of Afatinib and Paclitaxel are considered investigational when used in this research program. An investigational drug is a drug that is not approved by the FDA for its indication.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
Urothelial Carcinoma 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Gilotrif
Intervention Trials
Lung Neoplasms 6
Carcinoma, Non-Small-Cell Lung 5
Carcinoma 4
Carcinoma, Squamous Cell 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Gilotrif

Trials by Country

Trials by Country for Gilotrif
Location Trials
United States 40
Hong Kong 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Gilotrif
Location Trials
California 4
Tennessee 3
Illinois 2
New York 2
Massachusetts 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Gilotrif
Clinical Trial Phase Trials
Recruiting 7
Completed 2
Not yet recruiting 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Gilotrif

Sponsor Name

Sponsor Name for Gilotrif
Sponsor Trials
Boehringer Ingelheim 4
National Cancer Institute (NCI) 4
National Comprehensive Cancer Network 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Gilotrif
Sponsor Trials
Other 15
Industry 6
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Merck
Moodys
Boehringer Ingelheim
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.