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	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.
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

All Clinical Trials for NAVELBINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003587 ↗	S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-10-01	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: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
NCT00003587 ↗	S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Completed	Southwest Oncology Group	Phase 2	1998-10-01	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: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
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.
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.

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

Navelbine (Vinorelbine): Clinical Trials, Market Analysis, and Projections

Introduction

Navelbine, also known as vinorelbine, is a vinca alkaloid used in the treatment of various cancers, including breast cancer and non-small cell lung cancer. This article provides an update on recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

METEORA-II Trial

A significant clinical trial that has shed light on the efficacy of vinorelbine is the METEORA-II trial. This phase 2 randomized clinical trial compared the all-oral metronomic chemotherapy regimen of vinorelbine, cyclophosphamide, and capecitabine (VEX) with weekly intravenous paclitaxel in patients with estrogen receptor-positive (ER+), ERBB2-negative (ERBB2−) advanced breast cancer.

• Key Findings: The trial, involving 140 patients, showed that the VEX regimen significantly improved time to treatment failure (TTF) and progression-free survival (PFS) compared to paclitaxel. The median TTF was 8.3 months for VEX versus 5.7 months for paclitaxel, and the median PFS was 11.1 months for VEX versus 6.9 months for paclitaxel[1].

• Implications: These results suggest that the metronomic VEX regimen could be a viable chemotherapy option for patients with ER+/ERBB2− advanced breast cancer, offering more prolonged disease control.

Real-World Data

Real-world data from the Unicancer Epidemiology Strategy Medical-Economics (ESME) metastatic breast cancer database in France have also been analyzed to evaluate the efficacy and usage patterns of oral vinorelbine.

• Findings: The study, which collected data from 2008 to 2014, indicated that oral vinorelbine is effective in treating metastatic breast cancer, with a low toxicity profile and good tumor control. The oral formulation is considered economically viable and has been in use since its approval in France in 2001[2].

Market Analysis

Current Market Size

The global vinorelbine market has been growing steadily due to increasing demand for cancer treatments.

• Market Value: As of 2023, the vinorelbine market was valued at approximately USD 420 million[3].

Growth Projections

The market is expected to continue growing over the next few years.

• Forecast: The vinorelbine market is projected to reach USD 650 million by 2031, growing at a compound annual growth rate (CAGR) of 4.9% from 2024 to 2031[3].

Drivers of Growth

Several factors are driving the growth of the vinorelbine market:

• Increasing Cancer Incidence: The rising incidence of cancers such as breast cancer and non-small cell lung cancer is fueling the demand for vinorelbine[3].
• Advancements in Oncology: Research developments in oncology are highlighting the safety and efficacy of vinorelbine, particularly in combination treatments[3].
• Personalized Medicine: The increasing emphasis on personalized cancer therapies is boosting interest in customized vinorelbine treatments[3].
• New Formulations and Applications: Continuous clinical trials and research into new formulations and applications are expanding the therapeutic use and accessibility of vinorelbine[3].

Regional Analysis

The vinorelbine market is segmented into several major regions, including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

• Regional Insights: Each region has its own trends and growth rates. For instance, the Asia Pacific region is expected to see significant growth due to the increasing incidence of cancer and advancements in healthcare infrastructure[5].

Market Segmentation

The vinorelbine market is segmented based on type and application.

• Type: The market includes different formulations of vinorelbine, such as intravenous and oral forms. The oral formulation is particularly noted for its low toxicity profile and economic viability[2][5].
• Application: Vinorelbine is used in the treatment of various cancers, with breast cancer and non-small cell lung cancer being the primary applications[3][5].

Competitive Analysis

The vinorelbine market involves several competitors, and the competitive landscape is influenced by factors such as product pricing, production capacity, and supply-demand dynamics.

• Competitor Insights: Companies involved in the vinorelbine market are focusing on research and development to improve the safety and efficacy profiles of vinorelbine, as well as to explore new formulations and applications[5].

Future Prospects

Technological Trends

Advancements in technology, such as the development of new formulations and delivery systems, are expected to enhance the therapeutic use of vinorelbine.

• Metronomic Dosing: Early clinical trials suggest that metronomic dosing of vinorelbine might be as effective as traditional dosing methods, offering a new approach to cancer treatment[4].

Regulatory Environment

The regulatory environment plays a crucial role in the growth of the vinorelbine market. Approvals and guidelines set by health authorities influence the market's expansion.

• Regulatory Support: The approval of vinorelbine in various countries and the conduct of clinical trials according to international standards (such as the Declaration of Helsinki and ICH Guidelines for Good Clinical Practice) support the market's growth[1].

Key Takeaways

• Clinical Efficacy: Vinorelbine, particularly in combination regimens like VEX, has shown significant clinical efficacy in treating advanced breast cancer.
• Market Growth: The vinorelbine market is expected to grow at a CAGR of 4.9% from 2024 to 2031, driven by increasing cancer incidence and advancements in oncology.
• Regional Variations: The market is segmented into various regions, each with its own growth trends and drivers.
• Technological Advancements: New formulations and dosing methods, such as metronomic dosing, are expected to enhance the therapeutic use of vinorelbine.

FAQs

What is the current market size of vinorelbine?

The global vinorelbine market was valued at approximately USD 420 million in 2023[3].

What is the projected growth rate of the vinorelbine market?

The vinorelbine market is expected to grow at a CAGR of 4.9% from 2024 to 2031[3].

What are the primary applications of vinorelbine?

Vinorelbine is primarily used in the treatment of breast cancer and non-small cell lung cancer[3].

What are the key drivers of the vinorelbine market growth?

The key drivers include the increasing incidence of cancer, advancements in oncology, emphasis on personalized medicine, and continuous clinical trials and research into new formulations and applications[3].

What is the significance of the METEORA-II trial for vinorelbine?

The METEORA-II trial demonstrated that the all-oral metronomic chemotherapy regimen of vinorelbine, cyclophosphamide, and capecitabine (VEX) significantly improved time to treatment failure and progression-free survival compared to weekly intravenous paclitaxel in patients with ER+/ERBB2− advanced breast cancer[1].

Sources

1. JAMA Oncology: "Efficacy of Metronomic Oral Vinorelbine, Cyclophosphamide, and Capecitabine vs Weekly Paclitaxel for Patients With ER+/ERBB2− Advanced Breast Cancer: The METEORA-II Trial"[1].
2. International Journal of Radiation Oncology, Biology, Physics: "Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer"[2].
3. Market Research Intellect: "Vinorelbine Market Size and Projections"[3].
4. Future Oncology: "The NAME Trial: A Direct Comparison of Classical Oral Navelbine and Other Treatments"[4].
5. Cognitive Market Research: "Vinorelbine Market Report 2024 (Global Edition)"[5].