CLINICAL TRIALS PROFILE FOR CABAZITAXEL

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	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 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	Achieve Life Sciences	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)

Clinical Trial Conditions for cabazitaxel

Condition Name

Condition Name for cabazitaxel
Intervention	Trials
Prostate Cancer	37
Prostate Cancer Metastatic	9
Castration-Resistant Prostate Carcinoma	7
Metastatic Prostate Cancer	7

Condition MeSH

Condition MeSH for cabazitaxel
Intervention	Trials
Prostatic Neoplasms	86
Carcinoma	17
Neoplasms	8
Adenocarcinoma	6

Clinical Trial Locations for cabazitaxel

Trials by Country

Trials by Country for cabazitaxel
Location	Trials
United States	303
Canada	28
France	27
Spain	22
Australia	20

Trials by US State

Trials by US State for cabazitaxel
Location	Trials
California	20
New York	14
Texas	14
Ohio	14
Pennsylvania	13

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	4

Clinical Trial Status

Clinical Trial Status for cabazitaxel
Clinical Trial Phase	Trials
Completed	49
Recruiting	19
Terminated	18

Clinical Trial Sponsors for cabazitaxel

Sponsor Name

Sponsor Name for cabazitaxel
Sponsor	Trials
Sanofi	57
National Cancer Institute (NCI)	7
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for cabazitaxel
Sponsor	Trials
Other	160
Industry	98
NIH	7

Cabazitaxel Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Cabazitaxel

Introduction

Cabazitaxel is a chemotherapy medication used primarily in the treatment of metastatic castration-resistant prostate cancer (mCRPC), especially in patients who have previously received docetaxel. Here, we will delve into recent clinical trials, market analysis, and projections for this drug.

Recent Clinical Trials

Biweekly vs Triweekly Cabazitaxel in Older Patients

A significant phase 3 randomized clinical trial, known as the CABASTY study, compared the efficacy and safety of biweekly cabazitaxel (16 mg/m²) plus prophylactic granulocyte colony–stimulating factor (G-CSF) against the standard triweekly cabazitaxel (25 mg/m²) plus G-CSF in patients 65 years or older with mCRPC. The study enrolled 196 patients and found that the biweekly regimen significantly reduced the incidence of grade 3 or higher neutropenia and neutropenic complications by 12-fold compared to the triweekly regimen, with comparable clinical outcomes[1].

Combining Cabazitaxel and Carboplatin

Another ongoing clinical trial is investigating the combination of cabazitaxel and carboplatin for treating castrate-resistant prostate cancer, including the aggressive variant prostate cancer (AVPC). This study aims to determine if the combination of cabazitaxel and carboplatin works better than cabazitaxel alone in treating AVPC and non-AVPC prostate cancer, as well as its impact on overall survival and side effects. Previous smaller studies have suggested that this combination may be more effective, and this larger trial will provide more reliable results[4].

Market Analysis

Current Market Size and Growth

The global cabazitaxel market was valued at approximately USD 215.2 million in 2024 and is projected to grow to USD 293.4 million by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during this period[2].

Market Drivers

The growing incidence of cancer, particularly prostate cancer, and the increasing adoption of targeted therapies are key drivers of the cabazitaxel market. The need for effective treatments for patients who have failed other therapies, such as docetaxel, further fuels the demand for cabazitaxel[5].

Major Players

The cabazitaxel market is dominated by several key players, including Sanofi, Tapi Teva, Fuan Pharmaceutical Group, and Fujian Yewpark Biological. These companies play a crucial role in the production, distribution, and research and development of cabazitaxel[5].

Market Projections

Forecasted Market Size

By 2032, the global cabazitaxel market is expected to reach USD 0.33 billion, up from USD 0.2 billion in 2023, maintaining a CAGR of 5.3%[5].

Regional Market Share

The United States holds the largest market share, accounting for about 95% of the cabazitaxel market, followed by Europe with a smaller but significant share[2].

Segmentation

The market is segmented by type (purity above 99% and other purity levels) and application (patients below 65 years and above 65 years). Understanding these segments helps in tailoring marketing strategies and product development to meet specific patient needs[2].

Clinical and Market Implications

Safety and Efficacy

Clinical trials have shown that cabazitaxel, especially when administered in a biweekly regimen, can significantly reduce severe neutropenia and related complications, making it a safer option for older patients. This safety profile, combined with its efficacy, enhances its market appeal[1].

Combination Therapies

The ongoing trial combining cabazitaxel with carboplatin could open new avenues for treatment, potentially increasing the market size if the combination proves more effective than cabazitaxel alone[4].

Regulatory and Post-Marketing Requirements

The FDA has mandated several post-marketing studies to further evaluate the safety and pharmacokinetics of cabazitaxel, including its effects on QTc interval prolongation and its interaction with strong CYP3A4 inducers and inhibitors. These studies will continue to shape the drug's market presence and usage guidelines[3].

Key Takeaways

• Biweekly Cabazitaxel Regimen: Reduces severe neutropenia and related complications in older patients with mCRPC.
• Market Growth: Expected to grow from USD 215.2 million in 2024 to USD 293.4 million by 2030, with a CAGR of 5.3%.
• Major Players: Sanofi, Tapi Teva, Fuan Pharmaceutical Group, and Fujian Yewpark Biological are key players.
• Combination Therapies: Ongoing trials exploring the combination of cabazitaxel with carboplatin could expand treatment options.
• Safety and Efficacy: Clinical trials highlight the safety and efficacy of cabazitaxel, particularly in older patients.

FAQs

What is the primary use of cabazitaxel?

Cabazitaxel is primarily used in the treatment of metastatic castration-resistant prostate cancer (mCRPC), especially in patients who have previously received docetaxel.

How does the biweekly cabazitaxel regimen compare to the triweekly regimen?

The biweekly cabazitaxel regimen significantly reduces the incidence of grade 3 or higher neutropenia and neutropenic complications compared to the triweekly regimen, with comparable clinical outcomes.

What is the projected market size of cabazitaxel by 2030?

The global cabazitaxel market is projected to reach USD 293.4 million by 2030.

Which companies are the major players in the cabazitaxel market?

Sanofi, Tapi Teva, Fuan Pharmaceutical Group, and Fujian Yewpark Biological are the top companies operating in the cabazitaxel market.

What are the main drivers of the cabazitaxel market?

The growing incidence of cancer and the increasing adoption of targeted therapies are key drivers of the cabazitaxel market.

Sources

1. JAMA Oncology: "Biweekly vs Triweekly Cabazitaxel in Older Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Clinical Trial"[1].
2. Valuates Reports: "Global Cabazitaxel Market Insights, Forecast to 2030"[2].
3. FDA: "Clinical Pharmacology Review NDA 201023 - Cabazitaxel"[3].
4. SWOG: "Combining Cabazitaxel and Carboplatin to Treat Castrate-Resistant Prostate Cancer"[4].
5. Business Research Insights: "Cabazitaxel Market Size, Share | 2024 To 2032"[5].