CLINICAL TRIALS PROFILE FOR JEVTANA KIT

505(b)(2) Clinical Trials for Jevtana Kit

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	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	Janssen Services, LLC	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Combination	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	University of Colorado, Denver	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.

All Clinical Trials for Jevtana Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00417079 ↗	XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer	Completed	Sanofi	Phase 3	2007-01-01	This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
NCT01001221 ↗	Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor	Terminated	Sanofi	Phase 1/Phase 2	2009-11-01	Primary Objectives: - Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with gemcitabine, every 3 weeks in patients with advanced solid malignancies. - Study part 2: To determine the antitumor activity of cabazitaxel in combination with gemcitabine, in an additional extended cohort of 15 patients with advanced solid malignancies treated with the defined MTD, as assessed by objective response rate (ORR) according to the revised guideline for Response Evaluation Criteria in Solid Tumours (RECIST 1.1 criteria). Secondary Objectives: - To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine. - To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2' difluorodeoxyuridine (dFdU) when given in combination. - To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the study and the patients who received the MTD in Part 1 component. For study part 1, dose levels were to be escalated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further dose escalation when this dose was achieved. The MTD was defined as the highest dose at which 0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of treatment.
NCT01365130 ↗	Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen	Terminated	Rhode Island Hospital	Phase 2	2011-06-01	The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer
NCT01365130 ↗	Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen	Terminated	Roger Williams Medical Center	Phase 2	2011-06-01	The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer
NCT01365130 ↗	Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen	Terminated	The Miriam Hospital	Phase 2	2011-06-01	The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer

Clinical Trial Conditions for Jevtana Kit

Condition Name

Condition Name for Jevtana Kit
Intervention	Trials
Prostate Cancer	8
Castration-Resistant Prostate Carcinoma	6
Prostate Cancer Metastatic	4
Metastatic Prostate Carcinoma	4

Condition MeSH

Condition MeSH for Jevtana Kit
Intervention	Trials
Prostatic Neoplasms	32
Carcinoma	12
Neoplasms	6
Breast Neoplasms	5

Clinical Trial Locations for Jevtana Kit

Trials by Country

Trials by Country for Jevtana Kit
Location	Trials
United States	100
Spain	12
Canada	10
Belgium	9
France	9

Trials by US State

Trials by US State for Jevtana Kit
Location	Trials
Texas	6
Pennsylvania	5
Ohio	5
California	5
Maryland	5

Clinical Trial Progress for Jevtana Kit

Clinical Trial Phase

Clinical Trial Phase for Jevtana Kit
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Jevtana Kit
Clinical Trial Phase	Trials
Completed	17
Terminated	10
Active, not recruiting	8

Clinical Trial Sponsors for Jevtana Kit

Sponsor Name

Sponsor Name for Jevtana Kit
Sponsor	Trials
Sanofi	32
M.D. Anderson Cancer Center	5
National Cancer Institute (NCI)	5

Sponsor Type

Sponsor Type for Jevtana Kit
Sponsor	Trials
Other	63
Industry	45
NIH	5