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.

Clinical Trial Conditions for cabazitaxel

Condition Name

Condition Name for cabazitaxel
Intervention	Trials
Prostate Cancer	38
Prostate Cancer Metastatic	9
Castration-Resistant Prostate Carcinoma	9
Metastatic Prostate Cancer	8

Condition MeSH

Condition MeSH for cabazitaxel
Intervention	Trials
Prostatic Neoplasms	92
Carcinoma	17
Neoplasms	9
Adenocarcinoma	6

Clinical Trial Locations for cabazitaxel

Trials by Country

Trials by Country for cabazitaxel
Location	Trials
United States	380
France	32
Canada	32
Spain	30
Australia	29

Trials by US State

Trials by US State for cabazitaxel
Location	Trials
California	24
Ohio	19
New York	16
Florida	16
Pennsylvania	16

Clinical Trial Progress for cabazitaxel

Clinical Trial Phase

Clinical Trial Phase for cabazitaxel
Clinical Trial Phase	Trials
PHASE3	4
PHASE2	4
PHASE1	1

Clinical Trial Status

Clinical Trial Status for cabazitaxel
Clinical Trial Phase	Trials
Completed	49
RECRUITING	26
Terminated	18

Clinical Trial Sponsors for cabazitaxel

Sponsor Name

Sponsor Name for cabazitaxel
Sponsor	Trials
Sanofi	57
National Cancer Institute (NCI)	9
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for cabazitaxel
Sponsor	Trials
Other	163
Industry	104
NIH	9

Clinical Trials Update, Market Analysis, and Projection for Cabazitaxel

Last updated: October 28, 2025

Introduction

Cabazitaxel, a next-generation taxane-based chemotherapy agent, plays a pivotal role in the treatment of metastatic castration-resistant prostate cancer (mCRPC). As an approved option following docetaxel therapy, cabazitaxel's clinical development and market performance are closely monitored for potential expansion into other oncologic indications. This analysis provides a comprehensive update on ongoing clinical trials, evaluates current market dynamics, and projects future growth trajectories based on recent data.

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Clinical Trials Update

Current Phase and Key Ongoing Trials

Cabazitaxel's clinical landscape is marked by a steady progression of trials exploring novel combinations, alternative dosing regimens, and expanded indications.

• Phase III Trials:

  The pivotal TROPIC trial (NCT01308576) validated cabazitaxel's efficacy in mCRPC, leading to FDA approval in 2010. Currently, the focus shifts toward real-world studies and post-approval studies to refine its use parameters.

• Phase II/III Trials:

  Several ongoing studies aim to evaluate cabazitaxel in optimized combination therapies:

  • Combination with immunotherapy agents: Trials like NCT04582389 are exploring cabazitaxel with checkpoint inhibitors such as atezolizumab, targeting durable responses in prostate and other cancers.

  • Treatment in other cancers: Investigations are underway into its efficacy against ovarian (NCT04128250) and non-small cell lung cancers, hinting at broader applications.

• Registry and Real-World Evidence Studies:

  Countries like the U.S., EU, and China are conducting retrospective analyses (e.g., NCT04573001) to assess safety, tolerability, and effectiveness outside controlled trial environments.

Emerging Technologies and Formulations

Advancements include nanocarrier formulations to improve drug delivery and reduce toxicity. Notably, a liposomal version of cabazitaxel is in early-phase trials (NCT05193287), aiming to enhance tumor targeting while minimizing systemic adverse effects.

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Market Analysis

Current Market Status

Since its approval, cabazitaxel has established a significant presence, particularly within the prostate cancer treatment landscape.

• Sales and Revenue:

  According to IQVIA, the global sales of cabazitaxel approximated US$500 million in 2022, buoyed by its exclusive manufacturer, Janssen Pharmaceuticals.

• Market Share:

  In the prostate cancer segment, cabazitaxel competes with docetaxel, abiraterone, enzalutamide, and emerging oral therapeutics, commanding approximately 45% of the second-line metastatic hormone-resistant prostate cancer market segment.

• Pricing Dynamics:

  The drug's pricing varies across regions, with annual treatment costs ranging from US$40,000 to US$60,000, influenced by reimbursement policies and healthcare systems.

Competitive Landscape

• Existing Competitors:

  • Chemotherapy agents: Docetaxel remains a first-line, though cabazitaxel is preferred post-disease progression.

  • Hormonal therapies: Enzalutamide and abiraterone dominate the hormone-therapy space; however, cabazitaxel offers an effective alternative when hormonal therapies fail.

• Emerging Alternatives:

  Novel agents, including androgen receptor degraders and immunotherapies, risk diminishing cabazitaxel's share but also open doors for combination strategies.

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Market Outlook and Projections

Growth Drivers

• Expanding Indications: Trials suggest potential for cabazitaxel in breast, ovarian, and lung cancers.

• Combination Regimens: Evidence of synergy with immunotherapies and targeted agents could broaden its utility.

• Global Oncology Burden: Increasing cancer incidence particularly in aging populations enhances demand.

• Regulatory Approvals: Pending approvals or label expansions, particularly in Asia and Europe, will catalyze revenue streams.

Market Constraints

• Toxicity Profile: Neutropenia and diarrhea limit tolerability, prompting research into improved formulations.

• Cost and Accessibility: High treatment costs pose barriers, especially in low- to middle-income countries.

Projection: 2023-2028

Based on current trends:

• Compound Annual Growth Rate (CAGR): Estimated at approximately 8-10%, driven by expanded indications and combination therapies.

• Revenue Forecasts: Projected to reach US$850 million to US$1 billion globally by 2028, assuming successful clinical validations and market penetration in additional oncologic indications.

• Geographical Expansion: Greater focus on emerging markets (Asia-Pacific, Latin America), where unmet needs and rising cancer prevalence provide opportunities.

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Strategic Opportunities and Challenges

• Partnerships and Licensing: Collaborations with biotech firms working on nanocar technologies or combination drugs could accelerate market expansion.

• Pricing Strategies: Optimizing reimbursement pathways will be crucial in emerging markets to foster adoption.

• Regulatory Navigation: Efficient filings leveraging positive clinical data will accelerate approval cycles.

• Addressing Toxicity: Investing in novel delivery systems remains essential to improve safety profiles.

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Key Takeaways

• Evolving Clinical Landscape: Ongoing trials are exploring expanded indications and combination strategies, with some promising early results indicative of broader applicability.

• Market Position: Cabazitaxel remains a vital agent in metastatic prostate cancer, maintaining solid revenue despite competition.

• Future Growth: The drug’s market is poised for robust growth driven by clinical trials, regulatory expansions, and combination therapies.

• Investment Considerations: Companies involved should prioritize innovative formulations, strategic collaborations, and regulatory agility to capitalize on emerging opportunities.

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FAQs

1. What are the main indications for cabazitaxel currently approved by regulatory agencies?
Cabazitaxel is primarily approved for metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with docetaxel. It is also being investigated for other cancers, though these are not yet approved globally.

2. How does cabazitaxel differentiate from other taxane chemotherapies?
Cabazitaxel exhibits activity in docetaxel-resistant tumors, owing to its ability to evade P-glycoprotein-mediated drug efflux, a common resistance mechanism in cancer cells.

3. Are there ongoing efforts to improve cabazitaxel's safety profile?
Yes, research includes developing nanoparticle carriers and liposomal formulations designed to reduce toxicity while maintaining efficacy.

4. What is the outlook for cabazitaxel’s use beyond prostate cancer?
Early-phase trials suggest potential efficacy in ovarian, lung, and breast cancers, but regulatory approval will depend on positive trial outcomes.

5. How might market competition impact cabazitaxel’s future?
Emerging therapies and oral chemotherapeutic options could challenge cabazitaxel’s share, underscoring the need for combination strategies and formulation innovations.

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Sources

1. [1] European Medicines Agency – Cabazitaxel summary.
2. [2] IQVIA Market Reports – Oncology drug sales 2022.
3. [3] ClinicalTrials.gov – Ongoing trials involving cabazitaxel.
4. [4] Janssen Pharmaceuticals – Product information and clinical data.
5. [5] GlobalData – Oncology market projections 2023–2028.