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Last Updated: January 26, 2020

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CLINICAL TRIALS PROFILE FOR ERLOTINIB HYDROCHLORIDE

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505(b)(2) Clinical Trials for Erlotinib Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00130520 Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer Completed Genentech, Inc. Phase 2 2005-06-01 The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination NCT00130520 Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer Completed University of Arizona Phase 2 2005-06-01 The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination NCT02353741 Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC Recruiting Xinqiao Hospital of Chongqing Phase 2 2015-04-01 This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.
OTC NCT03513393 Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole. Not yet recruiting Radboud University Phase 1 2018-08-01 Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Erlotinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00026338 Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer Completed NCIC Clinical Trials Group Phase 3 2001-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
NCT00030446 Erlotinib and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Completed NCIC Clinical Trials Group Phase 2 2002-01-01 RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
NCT00030485 Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer Completed NCIC Clinical Trials Group Phase 2 2002-01-01 RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
NCT00030485 Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer Completed National Cancer Institute (NCI) Phase 2 2002-01-01 RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
NCT00030498 Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Completed National Cancer Institute (NCI) Phase 1 2001-12-01 Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
NCT00030537 Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 2001-11-01 RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.
NCT00030576 Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Completed National Cancer Institute (NCI) Phase 1/Phase 2 2001-11-01 RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Erlotinib Hydrochloride

Condition Name

Condition Name for Erlotinib Hydrochloride
Intervention Trials
Non-small Cell Lung Cancer 113
Lung Cancer 66
Carcinoma, Non-Small-Cell Lung 50
Pancreatic Cancer 47
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Condition MeSH

Condition MeSH for Erlotinib Hydrochloride
Intervention Trials
Carcinoma, Non-Small-Cell Lung 391
Lung Neoplasms 338
Carcinoma 81
Pancreatic Neoplasms 80
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Clinical Trial Locations for Erlotinib Hydrochloride

Trials by Country

Trials by Country for Erlotinib Hydrochloride
Location Trials
Korea, Republic of 98
Australia 93
France 92
Germany 88
United Kingdom 87
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Trials by US State

Trials by US State for Erlotinib Hydrochloride
Location Trials
California 159
Texas 143
New York 128
Florida 110
Illinois 106
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Clinical Trial Progress for Erlotinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Erlotinib Hydrochloride
Clinical Trial Phase Trials
Phase 4 19
Phase 3 87
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Erlotinib Hydrochloride
Clinical Trial Phase Trials
Completed 385
Active, not recruiting 106
Recruiting 99
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Clinical Trial Sponsors for Erlotinib Hydrochloride

Sponsor Name

Sponsor Name for Erlotinib Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 158
Genentech, Inc. 105
Hoffmann-La Roche 71
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Sponsor Type

Sponsor Type for Erlotinib Hydrochloride
Sponsor Trials
Other 756
Industry 503
NIH 159
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