CLINICAL TRIALS PROFILE FOR TARCEVA

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).

All Clinical Trials for TARCEVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026338 ↗	Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer	Completed	NCIC Clinical Trials Group	Phase 3	2001-10-29	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	Canadian Cancer Trials Group	Phase 3	2001-11-01	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	NCIC Clinical Trials Group	Phase 3	2001-11-01	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	2001-11-01	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	Canadian Cancer Trials Group	Phase 3	2001-11-29	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	NCIC Clinical Trials Group	Phase 3	2001-11-29	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.

Clinical Trial Conditions for TARCEVA

Condition Name

Condition Name for TARCEVA
Intervention	Trials
Non-Small Cell Lung Cancer	68
Lung Cancer	33
Pancreatic Cancer	31
Carcinoma, Non-Small-Cell Lung	24

Condition MeSH

Condition MeSH for TARCEVA
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	200
Lung Neoplasms	173
Carcinoma	46
Pancreatic Neoplasms	45

Clinical Trial Locations for TARCEVA

Trials by Country

Trials by Country for TARCEVA
Location	Trials
Italy	138
Canada	112
Spain	92
Australia	64
Brazil	62

Trials by US State

Trials by US State for TARCEVA
Location	Trials
California	86
Texas	86
Florida	67
New York	67
Ohio	54

Clinical Trial Progress for TARCEVA

Clinical Trial Phase

Clinical Trial Phase for TARCEVA
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	49
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for TARCEVA
Clinical Trial Phase	Trials
Completed	277
Terminated	77
Unknown status	29

Clinical Trial Sponsors for TARCEVA

Sponsor Name

Sponsor Name for TARCEVA
Sponsor	Trials
Genentech, Inc.	96
National Cancer Institute (NCI)	72
Hoffmann-La Roche	63

Sponsor Type

Sponsor Type for TARCEVA
Sponsor	Trials
Other	486
Industry	351
NIH	73