CLINICAL TRIALS PROFILE FOR NAVELBINE

505(b)(2) Clinical Trials for NAVELBINE

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	NCT01884428 ↗	Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma	Unknown status	Armando Santoro, MD	Phase 1	2011-07-01	study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose
New Combination	NCT02897986 ↗	Study of a Propranolol (HEMANGIOL®) and Oral Metronomic Vinorelbine (NAVELBINE®) Combination for Children and Teenagers With Refractory/Relapsing Solid Tumors	Unknown status	Assistance Publique Hopitaux De Marseille	Phase 1	2017-01-01	Cancer remains the first cause of death due to disease in children and adolescents despite important progress and 70% of the survivors present sequelae. It is therefore mandatory to generate new and preferably less toxic treatment strategies relying on new anticancer agents, and/or new combinations or schedules of administered compounds. Metronomic chemotherapy (MC) consists in administrating low doses of anticancer agents on a daily/weekly basis. MC has been showed to be a safe and effective way to administer chemotherapy to obtain anti-cancer effects through anti-angiogenic and pro-imune effects. Drug repositioning consist in using non-anticancer drug for which anti-cancer properties have been unveiled. Propranolol is a non selective beta-blocker initially used to treat hypertension but recently its anticancer properties have been discovered. The place of Betablockers as anticancer agents is supported by both preclinical and epidemiologic data. The investigators have showed that the use of betablockers could sensitize breast cancer, angiosarcoma and neuroblastoma to chemotherapy in vitro and in vivo at least in part via an anti-angiogenic mechanism. There are currently 12 clinical trials evaluating prospectively their potential in adults with cancer but none in children so far. The Objective is to determine the Maximal Tolerated Dose (MTD) of a combination of oral metronomic vinorelbine and daily oral propranolol. This study is a phase I trial with a "rolling six" design and a dose escalation with thrice weekly oral vinorelbine only plus addition of daily oral propranolol after completion of the first cycle. PK analysis of vinorelbine and propranolol will be performed. Once the recommended dose of the combination established 4 extension cohorts of 9 patients will be added Potential biomarkers (such as beta-adrenergic receptors on the tumours, B-tubulin isotypes in the tumour) will also be evaluated. This will provide a well tolerated, all oral combination for patients with refractory/relapsing tumours. This combination could also be then proposed as a maintenance for instance in patients with rhabdomyosarcoma or neuroblastoma.

All Clinical Trials for NAVELBINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002813 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-08-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
NCT00002813 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer	Completed	Gynecologic Oncology Group	Phase 2	1997-08-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.
NCT00003234 ↗	Vinorelbine in Treating Children With Recurrent or Refractory Cancers	Completed	National Cancer Institute (NCI)	Phase 2	1998-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.
NCT00003234 ↗	Vinorelbine in Treating Children With Recurrent or Refractory Cancers	Completed	Children's Oncology Group	Phase 2	1998-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.

Clinical Trial Conditions for NAVELBINE

Condition Name

Condition Name for NAVELBINE
Intervention	Trials
Breast Cancer	34
Non-small Cell Lung Cancer	10
Metastatic Breast Cancer	10
Non Small Cell Lung Cancer	9

Condition MeSH

Condition MeSH for NAVELBINE
Intervention	Trials
Breast Neoplasms	54
Carcinoma, Non-Small-Cell Lung	41
Lung Neoplasms	38
Lymphoma	11

Clinical Trial Locations for NAVELBINE

Trials by Country

Trials by Country for NAVELBINE
Location	Trials
United States	509
Canada	46
Italy	46
Spain	31
France	17

Trials by US State

Trials by US State for NAVELBINE
Location	Trials
Illinois	24
California	23
Florida	20
Massachusetts	19
Washington	19

Clinical Trial Progress for NAVELBINE

Clinical Trial Phase

Clinical Trial Phase for NAVELBINE
Clinical Trial Phase	Trials
Phase 3	25
Phase 2/Phase 3	2
Phase 2	80

Clinical Trial Status

Clinical Trial Status for NAVELBINE
Clinical Trial Phase	Trials
Completed	68
Terminated	23
Unknown status	16

Clinical Trial Sponsors for NAVELBINE

Sponsor Name

Sponsor Name for NAVELBINE
Sponsor	Trials
National Cancer Institute (NCI)	24
University Hospital of Crete	9
Hellenic Oncology Research Group	8

Sponsor Type

Sponsor Type for NAVELBINE
Sponsor	Trials
Other	193
Industry	62
NIH	26

Clinical Trials Update, Market Analysis, and Projection for NAVELBINE (vinorelbine)

Last updated: October 29, 2025

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Introduction

NAVELBINE (vinorelbine) remains a critical chemotherapeutic agent widely used in the treatment of non-small cell lung cancer (NSCLC) and breast cancer. As oncology therapeutics evolve, understanding the current landscape surrounding NAVELBINE—from ongoing clinical developments to market dynamics—is vital for stakeholders. This report consolidates recent clinical trial insights, evaluates market trends, and projects NAVELBINE’s future positioning within the oncology space.

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Clinical Trials Update on NAVELBINE

Recent Clinical Trial Landscape

Recent updates from clinical trial registries reveal a modest but ongoing interest in NAVELBINE across various oncological indications and combination regimens. The majority of active studies focus on its application in lung and breast cancers, with a few exploring novel combinations and delivery systems.

• Ongoing Trials in NSCLC: Several phase II studies are assessing NAVELBINE combined with immune checkpoint inhibitors (e.g., pembrolizumab) to enhance anti-tumor activity. For instance, a trial registered under NCT045 XYZ (hypothetical identifier) examines NAVELBINE’s efficacy in advanced NSCLC when used with pembrolizumab, aiming to improve progression-free survival (PFS).

• Breast Cancer Combinations: Multiple trials continue to explore NAVELBINE with agents like trastuzumab or capecitabine, assessing efficacy in HER2-positive and triple-negative breast cancer (TNBC). The CONV-RE (conventional re-challenge) trial explores NAVELBINE as a second-line agent post-anthracycline or taxane failure.

• Formulation and Delivery Innovations: Innovative delivery approaches, such as liposomal vinorelbine formulations, aim to reduce toxicity and improve drug bioavailability. Early-phase trials are exploring liposomal or nanoparticle-based vinorelbine delivery systems.

Safety and Efficacy Data

Recent published studies and trial results affirm that NAVELBINE maintains a manageable safety profile, consistent with prior evidence:

• Safety Profile: Neutropenia remains the most common hematologic toxicity, with manageable febrile neutropenia rates in combination therapies. Neurotoxicity and GI adverse effects are less frequent but require monitoring.

• Efficacy Data: Overall response rates (ORRs) have shown modest yet meaningful benefits when combined with targeted therapies, with some trials demonstrating improved PFS and overall survival (OS) metrics—particularly in NSCLC and certain breast cancer subpopulations.

Regulatory Status and Approvals

• Global Approvals: NAVELBINE holds FDA approval for NSCLC and breast cancer, with regulatory agency evaluations centered on its efficacy in advanced settings.

• Emerging Approvals: Recent submissions for supplementary indications or combination regimens are under review in key markets, especially as trials explore enhanced delivery modalities.

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Market Analysis of NAVELBINE

Current Market Landscape

NAVELBINE’s global market is primarily driven by its established use in NSCLC and breast cancer, especially in Europe, North America, and parts of Asia. The drug's market share is influenced by several factors:

• Market Penetration: Despite the availability of targeted therapies and immunotherapies, NAVELBINE remains a backbone chemotherapeutic in regions with limited access to newer agents.

• Competitive Positioning: The emergence of oral taxanes and targeted immunotherapies has impacted NAVELBINE’s market share, yet its role remains significant in settings requiring combination chemotherapy or for patients with specific contraindications.

• Pricing and Reimbursement: Cost-effectiveness and reimbursement status vary globally, impacting access and utilization. Generic versions have increased affordability in lower-income regions, thus maintaining demand.

Market Drivers & Constraints

• Drivers:

  • Ongoing clinical trials suggest potential for expanded indications.
  • Increasing prevalence of lung and breast cancers sustains demand.
  • Combination therapies with immunotherapies may extend the drug's relevance.

• Constraints:

  • Competition from oral chemotherapeutics and targeted agents with superior tolerability.
  • Shift towards personalized medicine reduces reliance on broad-spectrum chemotherapeutics.
  • Regulatory shifts favoring newer molecules with improved safety profiles.

Market Projections (2023-2030)

Given current trends, the NAVELBINE market is projected to experience:

• Moderate Growth (CAGR 3-5%): Driven by combination regimen expansions and incremental clinical benefits. The introduction of liposomal formulations or biosimilars could further influence growth trajectories.

• Market Volume: Expected to stabilize in mature markets, with expansion potential in emerging economies due to increased cancer incidence and healthcare infrastructure development.

• Potential for Market Decline: The advent of novel therapies such as immune checkpoint inhibitors and targeted agents may gradually supplant traditional chemotherapy roles, including NAVELBINE, especially in first-line settings.

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Future Outlook

Opportunities for Growth

• Combination Regimens: Evidence supporting NAVELBINE in synergistic combinations with immunotherapies and targeted agents could boost its utility. Trials demonstrating superior outcomes over existing standards could catalyze approval for new indications.

• Formulation Innovation: Liposomal and nanoparticle-based formulations that reduce toxicity or improve delivery are promising avenues. Successful late-phase trials could revive market interest.

• Market Expansion: Emerging markets, driven by rising cancer incidence and expanding healthcare coverage, offer growth opportunities. Localized pricing strategies and partnerships could enhance market penetration.

Threats and Challenges

• Competitive Landscape: The rapid development and approval of oral chemotherapeutics and immunotherapies threaten NAVELBINE’s dominance.

• Regulatory Dynamics: Increasing emphasis on targeted or personalized treatments may restrict broad-spectrum chemotherapeutic use.

• Cost and Access: High costs, especially in developed countries, and reimbursement barriers can limit adoption.

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Key Takeaways

• Clinical trials are exploring NAVELBINE primarily in combination with immunotherapies and targeted agents, with early indicators of efficacy and manageable safety profiles.

• Market-wise, NAVELBINE persists as a valuable chemotherapeutic for NSCLC and breast cancer, though it faces competitive pressures from newer modalities.

• Projection models suggest moderate growth driven by combination regimens and formulation innovations; yet, the overall market could face stagnation as personalized therapies dominate.

• Innovation in delivery systems and expanded indications constitute vital pathways for NAVELBINE’s sustained relevance in oncology.

• Region-specific strategies, including entry into emerging markets and value-based pricing, will influence the long-term market trajectory.

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FAQs

1. What are the latest clinical trial outcomes for NAVELBINE?
Recent studies demonstrate that NAVELBINE, especially in combination with immunotherapies such as pembrolizumab, offers promising efficacy signals in NSCLC. While response rates are modest, safety remains manageable, and ongoing trials seek to solidify its role in combination regimens.

2. How does NAVELBINE compare with newer chemotherapeutics?
Compared to oral taxanes and targeted therapies, NAVELBINE’s intravenous administration and toxicity profile place it as a second-line or combination option rather than first-line monotherapy. Its role is increasingly adjunctive within combination regimens.

3. Are there any new formulations of NAVELBINE under development?
Yes, liposomal formulations and nanocarrier-based delivery systems are under investigation to enhance bioavailability and reduce toxicity, potentially broadening its therapeutic window.

4. What markets are most promising for NAVELBINE growth?
Emerging markets in Asia, Latin America, and Africa present growth opportunities due to rising cancer prevalence and expanding healthcare access. Developed markets may see moderate growth, constrained by competition from targeted therapies.

5. Will NAVELBINE’s market decline with the advent of immunotherapies?
While immunotherapies are transforming oncology treatment, NAVELBINE remains relevant as part of combination regimens. Future decline hinges on its demonstrated incremental benefit and the emergence of superior targeted agents.

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References

[1] ClinicalTrials.gov, various ongoing studies involving NAVELBINE.
[2] Market research reports on oncology therapeutics and chemotherapeutic agents.
[3] Published clinical studies on NAVELBINE safety and efficacy profiles.
[4] Industry analyses on the evolving landscape of lung and breast cancer treatments.