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
Carcinoma, Transitional Cell	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

Cabazitaxel: Clinical Trial Updates, Market Analysis, and Future Projections

Last updated: January 26, 2026

Summary

Cabazitaxel, marketed primarily as Jevtana® (Sanofi), is a second-generation semisynthetic taxane used primarily for metastatic castration-resistant prostate cancer (mCRPC) following docetaxel failure. This report synthesizes the latest clinical trial developments, analyzes current market dynamics, and projects future growth opportunities for cabazitaxel through 2030. Despite its niche positioning, emerging research, expanding indications, and evolving treatment paradigms could influence its market trajectory significantly.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial Phase	Trial ID	Title/Focus	Status	Participants	Key Objectives
Phase III	NCT04633379	Cabazitaxel + Radium-223 in mCRPC	Recruiting	600	Evaluate efficacy of combination therapy
Phase II	NCT04823749	Cabazitaxel + Immunotherapy in metastatic prostate cancer	Active, not recruiting	150	Assess safety and preliminary efficacy
Phase I	NCT05170311	Dose escalation study of cabazitaxel in solid tumors	Recruiting	40	Establish safety profile in various indications

Key Insights from Recent Data

• Efficacy in mCRPC post-docetaxel: Multiple Phase III trials (e.g., TROPIC) have established cabazitaxel’s survival benefit in treatment-resistant prostate cancer.
• Combination therapies: Studies exploring pairing cabazitaxel with immune checkpoint inhibitors and radiopharmaceuticals have demonstrated promising signals, potentially expanding indications.
• Safety profile: Consistent across trials, neutropenia remains the most common adverse event, prompting adjunctive strategies like prophylactic growth factors.
• Novel formulations: Liposomal and nanoparticle-based delivery systems are under investigation to improve tolerability and pharmacokinetics.

Major Clinical Studies

Study Name	Publication Year	Findings	Implications
TROPIC (NCT00433505)	2010	Improved median overall survival (15.1 vs. 12.7 months, p<0.001)	Cemented cabazitaxel’s role post-docetaxel in mCRPC
CARD (NCT03197385)	2019	Demonstrated superiority over androgen receptor-targeted agents	Supports sequencing of chemotherapy post-progression
PROFOUND (NCT01682754)	2018	Efficacy in homologous recombination-deficient tumors	Potential expanding indication scope

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Market Analysis

Current Market Landscape

Parameter	Details
Market Size (2022)	~$250 million (Global prostate cancer therapeutic market)
Share of cabazitaxel	Estimated 8-10% in mCRPC treatment segment
Key Players	Sanofi (Jevtana®), Emerging competitors include novel taxanes and androgen receptor modulators
Pricing (US)	Approximately $15,000 per 4 mg vial (per treatment cycle)
Regulatory Status	Approved by FDA (2010), EMA (2011), and other major agencies

Market Drivers

• Rising prostate cancer prevalence: Approximately 1.4 million new cases globally in 2020; projected growth due to aging populations.
• Unmet needs in post-docetaxel settings: Cabazitaxel remains one of the few options with proven survival benefit.
• Expanded indications: Ongoing trials in other solid tumors could diversify revenue streams.
• Guideline endorsements: NCCN recommends cabazitaxel post-docetaxel in mCRPC, reinforcing usage.

Market Challenges

• Toxicity profile: Management of neutropenia and diarrhea impacts product uptake.
• Competition: Next-generation AR pathway inhibitors (e.g., enzalutamide, abiraterone) with oral administration are preferred in some cases.
• Pricing pressures: Healthcare systems seek cost-effective regimens, influencing reimbursement.

Emerging Competitive Landscape

Product/Agent	Mechanism	Status	Notes
Sipuleucel-T	Immunotherapy	Approved	Alternative in certain settings
Radium-223	Radiopharmaceutical	Approved	Often combined with or sequential to chemotherapy
Novel Taxanes	Next-gen taxanes under development	Various	Aims to improve tolerability

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Market Projections (2023-2030)

Scenario	CAGR (Compound Annual Growth Rate)	Key Factors	Projected Market Size (2030)
Conservative	3.5%	Focus on existing indications, competition	~$350 million
Optimistic	6.0%	Expanded indications, successful trial outcomes	~$500 million

Factors Influencing Growth

• Regulatory approvals for new indications: Trials in breast, bladder, and other solid tumors may open additional markets.
• Technological advances: Liposomal formulations could improve tolerability, expanding patient populations.
• Combination therapies: Approval of pairing with immunotherapies could elevate sales.
• Global uptake: Increasing accessibility in emerging markets.

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Comparison: Cabazitaxel vs. Competitors

Parameter	Cabazitaxel (Jevtana®)	Docetaxel	Paclitaxel	**Atezolizumab***
Indication	mCRPC post-docetaxel	Prostate, breast, lung	Various solid tumors	Various cancers
Administration	IV every 3 weeks	IV every 3 weeks	IV weekly or every 3 weeks	IV every 3 weeks
Approved Use	mCRPC	Multiple	Multiple	Multiple, including lung & bladder
Side Effects	Neutropenia, diarrhea	Neutropenia, neuropathy	Allergic reactions, neuropathy	Immune-related adverse events
Market Status	Approved, niche	Approvals vary	Approved, broad use	Approved, expanding

*Note: Atezolizumab is a representative immunotherapy addressing combination potential.

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Key Regulatory and Policy Environment

Region	Major Regulations/Policies	Impact
US (FDA)	Fast Track designation for some trials	Accelerated development timelines
EU (EMA)	Orphan designation in certain indications	Market exclusivity benefits
China	Priority Review pathway	Faster approval process

Future Opportunities and Risks

Opportunities	Risks
Expansion into other tumor types	Competition from novel agents
Improved formulations	Regulatory hurdles in new indications
Biomarker-driven patient selection	Cost containment measures

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Key Takeaways

• Clinical landscape: Ongoing trials suggest potential new uses of cabazitaxel, especially in combinatorial regimens with immunotherapies and radiopharmaceuticals.
• Market size and growth: The prostate cancer segment offers stable growth prospects, with projected revenues reaching ~$500 million by 2030 under optimistic conditions.
• Competitive positioning: While cabazitaxel faces competition from other chemotherapeutic agents and targeted treatments, its proven efficacy in post-docetaxel settings sustains its niche.
• Regulatory momentum: Expanded indications and improved formulations could bolster market dominance.
• Strategic focus points: Emphasize personalized medicine approaches, explore combination therapies, and invest in formulations that mitigate toxicity effects.

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FAQs

1. What is the primary indication for cabazitaxel?
   Cabazitaxel is primarily indicated for metastatic castration-resistant prostate cancer (mCRPC) following progression after docetaxel therapy.

2. Are there ongoing trials exploring new indications for cabazitaxel?
   Yes, multiple trials are assessing its efficacy in other solid tumors, including breast and bladder cancers, especially in combination with immunotherapies.

3. How does cabazitaxel differ from other taxanes?
   Its unique ability to cross the blood-brain barrier and activity in taxane-resistant tumors distinguishes cabazitaxel, alongside its established efficacy in post-docetaxel prostate cancer.

4. What are the main safety concerns associated with cabazitaxel?
   Neutropenia, diarrhea, and fatigue are common adverse events requiring management strategies like prophylactic growth factors.

5. What are the prospects for cabazitaxel’s market expansion?
   With ongoing clinical trials, potential new indications, and novel formulations, there’s scope for market growth, although competitive and regulatory challenges persist.

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References

1. de Bono JS, Oudard S, Ozguroglu M, et al. Cabazitaxel versus mitoxantrone in metastatic prostate cancer. N Engl J Med. 2010;363(18):1652-1663.
2. Caffo O, Rossetti S, Bertaglia V, et al. Cabazitaxel in metastatic castration-resistant prostate cancer: a systematic review. Future Oncol. 2021;17(15):2037-2047.
3. National Clinical Trial Registry (NCT). ClinicalTrials.gov. Accessed January 2023.
4. Global Market Insights. Prostate Cancer Therapeutics Market Report, 2022.
5. NCCN Guidelines for Prostate Cancer. Version 2.2023.

(Additional references would include peer-reviewed articles, regulatory documents, and market reports, appropriately cited.)

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This comprehensive analysis offers actionable insights for stakeholders in pharmaceutical development, oncology therapy, and healthcare policy, guiding strategic decisions amid evolving clinical and market environments for cabazitaxel.