CLINICAL TRIALS PROFILE FOR TESETAXEL

Clinical Trials for Tesetaxel

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01064713 ↗	Phase II Study of Tesetaxel in Metastatic Melanoma	Completed	Genta Incorporated	Phase 2	The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.
NCT01064713 ↗	Phase II Study of Tesetaxel in Metastatic Melanoma	Completed	M.D. Anderson Cancer Center	Phase 2	The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.
NCT01092585 ↗	Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH	Unknown status	Genta Incorporated	Phase 2	Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).
NCT01095120 ↗	Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer	Unknown status	Genta Incorporated	Phase 2	Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.
NCT01170975 ↗	Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules	Completed	Genta Incorporated	Phase 1	This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.
NCT01215877 ↗	Tesetaxel for Previously Treated Patients With Bladder Cancer	Unknown status	Genta Incorporated	Phase 2	The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients. Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.
NCT01221870 ↗	Tesetaxel as First-line Therapy for Metastatic Breast Cancer	Unknown status	Genta Incorporated	Phase 2	The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer. Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.

Clinical Trial Conditions for Tesetaxel

Condition Name

Condition Name
Intervention	Trials
Breast Cancer	3
Advanced Solid Tumors	2
Gastric Carcinoma	2
Locally Advanced Non-resectable Breast Cancer	1

Condition MeSH

Condition MeSH
Intervention	Trials
Breast Neoplasms	5
Stomach Neoplasms	3
Neoplasms	3
Melanoma	2

Clinical Trial Locations for Tesetaxel

Trials by Country

Trials by Country
Location	Trials
United States	65
Australia	6
Canada	6
Korea, Republic of	5
Germany	5

Trials by US State

Trials by US State
Location	Trials
Texas	9
New York	6
Tennessee	6
Pennsylvania	3
Virginia	3

Clinical Trial Progress for Tesetaxel

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	10
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Unknown status	10
Terminated	4
Completed	2

Clinical Trial Sponsors for Tesetaxel

Sponsor Name

Sponsor Name
Sponsor	Trials
Genta Incorporated	12
Odonate Therapeutics, Inc.	4
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	17
Other	1