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Last Updated: July 28, 2021

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CLINICAL TRIALS PROFILE FOR CABAZITAXEL

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505(b)(2) Clinical Trials for Cabazitaxel

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 Active, not recruiting 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 Active, not recruiting 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cabazitaxel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00925743 ↗ A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer Completed Sanofi Phase 1 2009-06-01 This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively). There are 4 parts to the study: Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety. Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients. Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel. Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
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.
NCT01083615 ↗ A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Terminated Teva Pharmaceuticals USA Phase 3 2010-03-01 The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.
NCT01083615 ↗ A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Terminated OncoGenex Technologies Phase 3 2010-03-01 The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.
NCT01087021 ↗ Effect of Cabazitaxel on the QTc Interval in Cancer Patients Completed Sanofi Phase 1 2010-03-01 Primary Objective: - To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: - To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals - To assess the clinical safety of cabazitaxel - To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
NCT01140607 ↗ Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment Completed Sanofi Phase 1 2010-05-01 Primary Objectives: - To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment - To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees of hepatic impairment - To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide prescribers with regard to dosing in this patient population - To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme activity using midazolam as probe in an additional cohort of cancer patients with normal hepatic function.
NCT01254279 ↗ Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen Completed Sanofi Phase 3 2010-12-01 The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cabazitaxel

Condition Name

Condition Name for Cabazitaxel
Intervention Trials
Prostate Cancer 35
Prostate Cancer Metastatic 8
Metastatic Prostate Cancer 6
Breast Cancer 4
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Condition MeSH

Condition MeSH for Cabazitaxel
Intervention Trials
Prostatic Neoplasms 73
Carcinoma 14
Neoplasms 6
Carcinoma, Transitional Cell 6
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Clinical Trial Locations for Cabazitaxel

Trials by Country

Trials by Country for Cabazitaxel
Location Trials
United States 272
France 27
Canada 24
Spain 19
United Kingdom 14
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Trials by US State

Trials by US State for Cabazitaxel
Location Trials
California 18
New York 14
Ohio 14
Texas 13
Florida 12
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Clinical Trial Progress for Cabazitaxel

Clinical Trial Phase

Clinical Trial Phase for Cabazitaxel
Clinical Trial Phase Trials
Phase 4 6
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Cabazitaxel
Clinical Trial Phase Trials
Completed 31
Recruiting 29
Not yet recruiting 22
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Clinical Trial Sponsors for Cabazitaxel

Sponsor Name

Sponsor Name for Cabazitaxel
Sponsor Trials
Sanofi 54
National Cancer Institute (NCI) 5
M.D. Anderson Cancer Center 5
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Sponsor Type

Sponsor Type for Cabazitaxel
Sponsor Trials
Other 112
Industry 86
NIH 5
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