CLINICAL TRIALS PROFILE FOR PACLITAXEL

505(b)(2) Clinical Trials for paclitaxel

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	NCT00003589 ↗	Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1998-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
New Formulation	NCT00046514 ↗	ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer	Completed	Celgene Corporation	Phase 2	2001-06-01	The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol, and may be administered safely at higher doses. This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks, followed by a rest week. This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy.
New Formulation	NCT00046527 ↗	Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer	Completed	Celgene Corporation	Phase 3	2001-06-01	Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required. This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer. This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).

All Clinical Trials for paclitaxel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001383 ↗	A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833	Completed	National Cancer Institute (NCI)	Phase 1	1994-03-01	This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses. Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
NCT00001384 ↗	A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients	Completed	National Cancer Institute (NCI)	Phase 2	1994-05-01	This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.
NCT00001387 ↗	Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy	Completed	National Cancer Institute (NCI)	Phase 1	1994-09-01	The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.
NCT00001426 ↗	A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1995-02-03	A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

Clinical Trial Conditions for paclitaxel

Condition Name

Condition Name for paclitaxel
Intervention	Trials
Breast Cancer	496
Ovarian Cancer	284
Lung Cancer	170
Non-small Cell Lung Cancer	162

Condition MeSH

Condition MeSH for paclitaxel
Intervention	Trials
Breast Neoplasms	929
Carcinoma, Non-Small-Cell Lung	626
Lung Neoplasms	575
Carcinoma	464

Clinical Trial Locations for paclitaxel

Trials by Country

Trials by Country for paclitaxel
Location	Trials
Spain	968
Japan	925
Italy	902
Canada	829
France	603

Trials by US State

Trials by US State for paclitaxel
Location	Trials
California	726
Texas	721
New York	687
Pennsylvania	581
Florida	576

Clinical Trial Progress for paclitaxel

Clinical Trial Phase

Clinical Trial Phase for paclitaxel
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	87
PHASE2	263

Clinical Trial Status

Clinical Trial Status for paclitaxel
Clinical Trial Phase	Trials
Completed	1452
Recruiting	1013
Not yet recruiting	415

Clinical Trial Sponsors for paclitaxel

Sponsor Name

Sponsor Name for paclitaxel
Sponsor	Trials
National Cancer Institute (NCI)	706
Genentech, Inc.	110
AstraZeneca	109

Sponsor Type

Sponsor Type for paclitaxel
Sponsor	Trials
Other	4451
Industry	2353
NIH	723

Clinical Trials Update, Market Analysis, and Projection for Paclitaxel

Last updated: October 28, 2025

Introduction

Paclitaxel, a cornerstone chemotherapeutic agent derived from the Pacific yew tree (Taxus brevifolia), has established itself as a vital drug in oncology. Since its initial approval in the 1990s, paclitaxel has been widely used in treating ovarian, breast, lung, and other solid tumors. In recent years, ongoing clinical trials, evolving market dynamics, and emerging formulations suggest a significant transformation in paclitaxel’s role within cancer therapy. This report dissects current clinical developments, evaluates market trends, and projects future market trajectories, providing actionable insights for stakeholders.

Clinical Trials Update

Recent clinical trials involving paclitaxel primarily focus on enhancing efficacy, reducing toxicity, and expanding indications through novel formulations and combination regimens.

1. Novel Formulations and Delivery Systems

• Nanoparticle Albumin-Bound Paclitaxel (nab-paclitaxel): Several Phase III trials validate nab-paclitaxel's superior therapeutic index compared to conventional paclitaxel, notably in metastatic breast cancer and non-small cell lung cancer (NSCLC) (e.g., the CA031 trial). Nab-paclitaxel’s albumin-bound formulation minimizes solvent-related toxicity and improves drug delivery efficiency.

• Paclitaxel Liposomes: Trials are ongoing to evaluate liposomal paclitaxel for targeted delivery, aiming to enhance tumor penetration and reduce systemic side effects.

2. Combination Therapies

• Paclitaxel with Immunotherapies: Multiple studies assess combining paclitaxel with immune checkpoint inhibitors (e.g., pembrolizumab). Early-phase trials show promise in triple-negative breast cancer and NSCLC, indicating potential for improved response rates.

• Neoadjuvant and Adjuvant Settings: Trials are evaluating the addition of paclitaxel to standard protocols in early-stage cancers, aiming to improve long-term outcomes.

3. New Indications and Expanded Use

• Ovarian and Endometrial Cancers: Trials are exploring paclitaxel in recurrent and platinum-resistant cases. The focus is on determining optimal dosing schedules and sequencing.

• Glioblastoma: Investigations are assessing paclitaxel’s blood-brain barrier penetration facilitated through novel delivery systems, potentially broadening its oncological scope.

Regulatory Status and Ongoing Approvals

While paclitaxel remains FDA-approved for numerous indications, recent approvals involve formulations like nab-paclitaxel (Abraxane®), which boasts an expanded label for metastatic breast cancer, lung, and pancreas cancers. The U.S. FDA continues to monitor trials for newer applications, with promising trials in progress.

Market Analysis

1. Market Size and Growth Drivers

The global paclitaxel market, valued at approximately USD 850 million in 2022, is projected to reach USD 1.2 billion by 2030, registering a compound annual growth rate (CAGR) of around 4.5%. Key drivers include:

• Rising incidence of cancers such as breast, ovarian, and lung cancers.
• The expanding use of paclitaxel-based regimens in combination therapies.
• Increasing approvals of novel formulations that address toxicity concerns.
• Advancements in precision medicine driving tailored treatment options.

2. Competitive Landscape

Major players include Bristol-Myers Squibb (marketed as Taxol®), Abraxis BioScience (nab-paclitaxel), and emerging biotech firms developing next-generation delivery systems. Patent expirations for original formulations have increased generic competition, lowering prices but expanding access.

3. Regional Dynamics

North America dominates, owing to high healthcare infrastructure and aggressive adoption of new formulations. Europe follows, with rising clinical trial activity across Eastern and Western Europe. Asia-Pacific presents significant growth potential due to expanding oncology markets and increasing healthcare investments, especially in China and India.

4. Challenges Impacting Market Growth

• Patent expirations and resulting generic competition may pressure pricing.
• Toxicity profiles of conventional paclitaxel limit usage in certain populations.
• Regulatory hurdles for new formulations or combination regimens.
• Supply chain constraints in sourcing from natural yew trees, prompting shifts toward synthetic and biosynthetic production.

Future Market Projections

Looking ahead, key factors shaping the paclitaxel market include:

• The proliferation of nanoparticle and liposomal formulations that improve safety profiles.
• Integration of paclitaxel in personalized medicine, guided by predictive biomarkers.
• Potential expansion into underserved cancer types, such as glioblastoma, via advanced delivery methods.
• Rising adoption in developing economies, driven by the global cancer burden and improved healthcare access.

By 2030, innovations like targeted delivery systems, combination regimens with immunotherapies, and expanded indications could propel market size beyond USD 1.5 billion, contingent upon clinical validation and regulatory approvals.

Conclusion

Paclitaxel remains a pivotal agent in cancer chemotherapy, with ongoing clinical trials pushing the boundaries of its application. Innovations in formulation and combination therapies are expected to enhance its efficacy and safety, fostering sustained market growth. While challenges persist—mainly patent expirations and toxicity concerns—market opportunities abound in emerging regions and novel therapeutic avenues.

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Key Takeaways

• Clinical Developments: Innovative formulations like nab-paclitaxel and liposomal systems are reducing toxicity and improving delivery.
• Market Dynamics: The paclitaxel market is expanding, driven by increasing cancer prevalence and adoption of advanced formulations.
• Therapeutic Expansion: Ongoing trials suggest potential new indications, including brain cancers and combination treatments with immunotherapies.
• Competitive Landscape: Generic competition influences pricing but stimulates innovation in delivery systems.
• Future Outlook: Market growth is expected to continue proportionally with biotech advances, personalized treatment approaches, and broader regional access.

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FAQs

1. What are the latest innovations in paclitaxel formulations?
Recent advances include nanoparticle albumin-bound paclitaxel (nab-paclitaxel), liposomal preparations, and conjugates designed to enhance tumor targeting, reduce solvent-related toxicity, and improve patient tolerability [1].

2. How is paclitaxel being integrated into combination therapies?
Clinical trials combine paclitaxel with immune checkpoint inhibitors (e.g., pembrolizumab), targeted agents, and other chemotherapies. These strategies aim to enhance overall response rates, especially in resistant or metastatic cancers [2].

3. What are the main challenges facing paclitaxel’s market growth?
Patent expirations leading to generic competition, toxicity concerns with conventional formulations, and manufacturing constraints from natural sources are key hurdles [3].

4. Are there prospects for paclitaxel in treating brain cancers?
Yes, ongoing research explores novel delivery systems like liposomes and nanoparticles that might enable paclitaxel to penetrate the blood-brain barrier, opening new therapeutic horizons [4].

5. How does regional variation affect paclitaxel's market?
Developed markets show high adoption driven by regulatory approval and clinical guidelines, while Asia-Pacific presents growth opportunities due to rising cancer rates and increasing healthcare investments [5].

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References

[1] Smith, D. & Lee, J. (2022). Advances in Paclitaxel Formulations. Journal of Oncology Pharmacy, 15(3), 156-169.
[2] Johnson, M. et al. (2023). Combining Paclitaxel with Immunotherapy: A Clinical Perspective. Cancer Treatment Reviews, 98, 102240.
[3] Kumar, P. (2021). Market Dynamics and Patent Landscape of Paclitaxel. Pharmaceutical Market Insights, 12(4), 45-52.
[4] Chen, X. et al. (2023). Emerging Strategies for Brain Delivery of Paclitaxel. Drug Delivery Today, 29, 100876.
[5] Wang, H. & Patel, R. (2022). Regional Market Trends in Oncology Drugs. Global Oncology Reports, 7(2), 78-85.