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
Castration-Resistant Prostate Carcinoma	9
Prostate Cancer Metastatic	9
Metastatic Prostate Cancer	8

Condition MeSH

Condition MeSH for CABAZITAXEL
Intervention	Trials
Prostatic Neoplasms	92
Carcinoma	17
Neoplasms	9
Prostatic Neoplasms, Castration-Resistant	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

Last updated: April 25, 2026

Cabazitaxel: Clinical Trials Update, Market Analysis, and Projection

What is cabazitaxel’s current clinical and regulatory footprint?

Cabazitaxel is a taxane chemotherapy approved for metastatic castration-resistant prostate cancer (mCRPC) after progression on docetaxel. The commercial product basis is Jevtana (cabazitaxel), administered with prednisone (or prednisolone). In practice, cabazitaxel use is driven by sequencing decisions in mCRPC and by toxicity management (notably neutropenia) that shapes uptake and adherence.

Key clinical trial themes in recent years have centered on:

• Earlier-line strategies in prostate cancer.
• Expanded use in other solid tumors with taxane-sensitive biology.
• Dosing schedules and prophylaxis optimization to mitigate neutropenia and treatment discontinuation.
• Combination regimens designed to improve response without adding prohibitive toxicity.

Cabazitaxel is also a platform molecule for:

• Combination chemotherapy (with agents that may potentiate cytotoxicity or overcome resistance).
• Targeted/precision add-ons in selected biomarker-defined subgroups.
• Alternate schedules (including modifications to dose intensity) to improve tolerability.

How does the pipeline look across major next-use indications?

The most decision-relevant pipeline structure is “where cabazitaxel could shift in standard of care.” That usually maps to three commercial vectors: earlier prostate adoption, expansion beyond prostate, and improved safety that increases achievable dose intensity.

Below is the practical trial landscape structure used by sponsors and evaluators when forecasting uptake.

Prostate cancer (primary commercial vector)

The key determinants for cabazitaxel uptake are:

• Evidence of benefit in earlier lines than post-docetaxel progression.
• Evidence that combinations improve outcomes without unacceptable rates of grade 3 to 5 adverse events.
• Use of prophylaxis standards and supportive care consistent with real-world dosing.

In mCRPC, cabazitaxel’s “ceiling” is set by:

• Competing standard agents (new androgen receptor pathway inhibitors earlier in the disease course).
• How quickly patients exhaust those agents and reach docetaxel and then cabazitaxel.

Other solid tumors (secondary vector)

For non-prostate indications, uptake is contingent on:

• Demonstrated benefit in phase 3 or definitive phase 2 with clear endpoints.
• A manageable safety profile in the target population.
• If biologic selection is feasible, enrichment that improves response rates.

The market typically responds to:

• A phase 2 signal that is strong on both response and survival endpoints.
• A phase 3 that validates benefit in a broader population.

What endpoints determine whether cabazitaxel gains share?

Across cabazitaxel trials and label expansions, the outcomes that most influence market access and prescribing are:

• Overall survival (OS) and progression-free survival (PFS).
• Objective response rate (ORR) in single-arm or non-randomized programs that support regulatory filings.
• Duration of response (DoR) in tumor settings where response is used.
• Neutropenia rates (any-grade and grade ≥3), febrile neutropenia, and treatment discontinuation.
• Dose reductions and ability to maintain dose intensity, which directly affect perceived “real-world efficacy.”

The commercial implication is direct: programs that reduce high-grade neutropenia or reduce discontinuation can raise effective patient throughput and physician willingness to select cabazitaxel earlier.

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Market Analysis: Cabazitaxel Demand, Pricing Power, and Competitive Structure

What drives cabazitaxel demand in mCRPC?

Cabazitaxel demand is driven by:

• The size of the mCRPC population that receives docetaxel and then progresses.
• Real-world sequencing after androgen receptor pathway inhibitors (ARPIs).
• Physician and payer willingness to continue taxane chemotherapy after docetaxel.

Cabazitaxel has structural advantages:

• It targets a taxane microtubule mechanism distinct from ARPIs.
• It has an established place in mCRPC after docetaxel.
• It is supported by a large body of practice experience.

Demand pressure comes from:

• Increasing use of earlier lines of therapy that can shift the post-docetaxel pool.
• Alternative post-docetaxel options in some settings (including radioligand therapy and other systemic regimens depending on geography and patient characteristics).
• Safety management constraints (neutropenia) that can limit use in frail patients.

How does competition shape market outcomes?

Competition in cabazitaxel’s commercial lane includes:

• Other cytotoxic regimens in mCRPC post-docetaxel.
• Radioligand strategies (for eligible patients, depending on region and biomarker status).
• ARPI- and PARP-based strategies that can move earlier lines and shrink later-line pools.
• Novel agents that may displace cabazitaxel in specific molecularly defined segments or in the context of combination regimens.

The practical effect:

• Cabazitaxel’s growth is most sensitive to whether it moves earlier in sequencing and whether it retains performance in more heavily pretreated populations.

What does the sales base look like (global and regional logic)?

Cabazitaxel markets are typically characterized by:

• High utilization concentration in the US and major EU markets due to reimbursement structure.
• Strong uptake where guideline-concordant use is supported.
• Variation in adoption driven by supportive care practices and access to prophylactic G-CSF.

A robust forecast requires exact current-year sales by geography and payer status. That data is not provided here, so the analysis below focuses on forecast mechanics, not point estimates.

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Market Projection: Scenarios for 2025–2035 Adoption

What are the scenario levers for cabazitaxel growth?

Use four levers:

1) Sequencing shift
If cabazitaxel secures stronger evidence for earlier use (before later-line progression), the treatable pool expands.

2) Safety and tolerability
If dosing or prophylaxis strategies reduce grade ≥3 neutropenia and discontinuation, physicians can sustain dose intensity and broaden the eligible patient population.

3) Combination regimens and biomarker selection
Regimens that improve ORR and survival in defined groups can increase uptake even without changing the overall sequencing.

4) Competitive displacement
If radioligand or targeted systemic regimens more effectively displace cabazitaxel in later lines, growth slows even when mCRPC prevalence rises.

What is the base-case adoption model?

A base-case market projection should reflect:

• Stable retention of label indications (no immediate large label loss).
• Gradual share capture driven by mCRPC progression epidemiology.
• Partial offset from earlier-line displacement by ARPIs and other modalities.

Under a base-case, cabazitaxel demand grows at the rate of:

• mCRPC incidence growth and treatment intensity changes,
• minus competitive displacement effects.

What would upside require?

Upside comes from:

• Positive phase 3 outcomes that move cabazitaxel earlier or expand to a new solid tumor with clear benefit.
• Safety improvements that increase eligible patient share.
• Adoption of guideline updates that normalize cabazitaxel use in broader subpopulations.

Upside typically increases both:

• the number of treated patients and
• the proportion of patients who complete multiple cycles.

What would downside require?

Downside comes from:

• Trial results that show limited incremental benefit versus alternatives.
• Safety signals that reduce tolerability at scale (real-world discontinuation).
• Stronger displacement by radioligand or other post-docetaxel strategies in specific populations.

Downside tends to reduce:

• initial uptake and
• continuation rates across cycles.

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Key Clinical Programs to Watch (Decision-Relevant Signals)

Which trial outcomes most affect cabazitaxel’s market forecast?

Market-moving outcomes for cabazitaxel are:

• OS improvement or PFS improvement that is clinically meaningful and consistent across subgroups.
• Reduced grade ≥3 neutropenia or febrile neutropenia through dosing changes, prophylaxis standards, or combination design.
• Trials that demonstrate benefit in populations that otherwise would not reach cabazitaxel under current sequencing.

What safety and dosing signals matter commercially?

• Treatment discontinuation rates and dose reductions.
• Febrile neutropenia rates.
• Time on therapy and delivered dose intensity.
• Prophylactic G-CSF practice alignment (where supported by evidence and label guidance).

These metrics translate into physician confidence and payer authorization decisions.

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Key Takeaways

• Cabazitaxel’s near-term market position remains anchored in post-docetaxel mCRPC, where sequencing depth determines addressable demand.
• Market growth hinges on whether trial evidence shifts cabazitaxel earlier in therapy, improves tolerability in real-world-like settings, or expands into additional solid tumor indications.
• Forecasts should treat neutropenia control and ability to maintain dose intensity as central drivers of adoption, not secondary considerations.
• Upside is highest when phase 3 data show survival benefit with a safety profile that broadens eligible patients.
• Downside is most likely if radioligand and newer systemic options more effectively displace cabazitaxel in later lines or if combination strategies fail on tolerability at scale.

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FAQs

1) What is cabazitaxel’s approved core indication?

Cabazitaxel (Jevtana) is approved for metastatic castration-resistant prostate cancer after progression on docetaxel, typically in combination with prednisone or prednisolone.

2) What is the main clinical risk that shapes real-world adoption?

Neutropenia, including grade ≥3 neutropenia and febrile neutropenia, drives dosing modifications, discontinuation, and supportive care practices.

3) What trial results would most increase market share?

Phase 3 OS or robust PFS benefit that also maintains or improves safety, plus evidence supporting earlier-line use.

4) Why does sequencing matter so much for cabazitaxel sales?

Because cabazitaxel is used after specific prior therapies. ARPI and other modalities in earlier lines can change how many patients reach the post-docetaxel window.

5) What is the most credible path to expansion beyond prostate?

Demonstrated survival or clinically meaningful endpoints in solid tumor phase 2/3 trials with a tolerable safety profile and, where possible, biomarker-supported enrichment.

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References

[1] FDA. Jevtana (cabazitaxel) Prescribing Information. U.S. Food and Drug Administration.
[2] European Medicines Agency (EMA). Jevtana: EPAR (Assessment Report) and Product Information. European Medicines Agency.