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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR JEVTANA KIT

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Clinical Trials for Jevtana Kit

Trial ID Title Status Sponsor Phase Summary
NCT00417079 XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer Completed Sanofi Phase 3 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 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 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
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Jevtana Kit

Condition Name

Condition Name for Jevtana Kit
Intervention Trials
Prostate Cancer 7
Prostate Cancer Metastatic 4
Prostatic Neoplasms 3
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Condition MeSH

Condition MeSH for Jevtana Kit
Intervention Trials
Prostatic Neoplasms 25
Carcinoma 8
Carcinoma, Transitional Cell 4
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Clinical Trial Locations for Jevtana Kit

Trials by Country

Trials by Country for Jevtana Kit
Location Trials
United States 84
Canada 10
Belgium 9
Spain 9
France 8
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Trials by US State

Trials by US State for Jevtana Kit
Location Trials
Texas 5
Maryland 5
Pennsylvania 5
Ohio 5
California 5
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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
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Clinical Trial Status

Clinical Trial Status for Jevtana Kit
Clinical Trial Phase Trials
Recruiting 15
Completed 8
Withdrawn 6
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Clinical Trial Sponsors for Jevtana Kit

Sponsor Name

Sponsor Name for Jevtana Kit
Sponsor Trials
Sanofi 30
M.D. Anderson Cancer Center 4
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Jevtana Kit
Sponsor Trials
Other 42
Industry 38
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
UBS
Dow
Citi
Cantor Fitzgerald
Chinese Patent Office
Harvard Business School
Healthtrust
Moodys

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