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Last Updated: November 26, 2020

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CLINICAL TRIALS PROFILE FOR TARCEVA

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505(b)(2) Clinical Trials for Tarceva

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).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tarceva

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.
NCT00036647 OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Completed NCIC Clinical Trials Group Phase 3 2001-10-01 The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
NCT00036647 OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Completed OSI Pharmaceuticals Phase 3 2001-10-01 The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
NCT00040183 OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer. Completed NCIC Clinical Trials Group Phase 3 2001-10-01 The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.
NCT00040183 OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer. Completed OSI Pharmaceuticals Phase 3 2001-10-01 The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.
NCT00043823 Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Completed Genentech, Inc. Phase 1/Phase 2 2002-08-01 Primary Objectives: 1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC). 2. (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study. Secondary Objectives: 1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination. 2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
NCT00043823 Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Completed Vanderbilt-Ingram Cancer Center Phase 1/Phase 2 2002-08-01 Primary Objectives: 1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC). 2. (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study. Secondary Objectives: 1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination. 2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tarceva

Condition Name

Condition Name for Tarceva
Intervention Trials
Non-small Cell Lung Cancer 63
Pancreatic Cancer 29
Lung Cancer 29
Carcinoma, Non-Small-Cell Lung 22
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Condition MeSH

Condition MeSH for Tarceva
Intervention Trials
Carcinoma, Non-Small-Cell Lung 175
Lung Neoplasms 147
Pancreatic Neoplasms 39
Carcinoma 31
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Clinical Trial Locations for Tarceva

Trials by Country

Trials by Country for Tarceva
Location Trials
United States 975
Italy 135
Canada 96
Spain 88
Australia 64
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Trials by US State

Trials by US State for Tarceva
Location Trials
Texas 73
California 61
Florida 52
New York 51
Tennessee 41
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Clinical Trial Progress for Tarceva

Clinical Trial Phase

Clinical Trial Phase for Tarceva
Clinical Trial Phase Trials
Phase 4 10
Phase 3 43
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Tarceva
Clinical Trial Phase Trials
Completed 208
Terminated 54
Active, not recruiting 45
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Clinical Trial Sponsors for Tarceva

Sponsor Name

Sponsor Name for Tarceva
Sponsor Trials
Genentech, Inc. 89
Hoffmann-La Roche 61
OSI Pharmaceuticals 43
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Sponsor Type

Sponsor Type for Tarceva
Sponsor Trials
Other 402
Industry 312
NIH 34
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