CLINICAL TRIALS PROFILE FOR VOTRIENT

All Clinical Trials for VOTRIENT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00454142 ↗	Pazopanib Hydrochloride in Treating Patients With Stage IV or Recurrent Nasopharyngeal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2007-08-01	This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT00454363 ↗	Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2007-03-01	This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced neuroendocrine cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
NCT00450879 ↗	Pazopanib in Treating Patients With Newly Diagnosed or Locally and/or Regionally Recurrent Breast Cancer That Can Be Removed By Surgery	Terminated	National Cancer Institute (NCI)	Phase 1	2007-01-01	This pilot clinical trial studies how well pazopanib hydrochloride works in treating patients with breast cancer that is newly diagnosed or has come back at or near the same place as the original tumor and can be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by preventing the growth of new blood vessels necessary for tumor growth. Giving pazopanib hydrochloride before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed.
NCT00388076 ↗	Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)	Completed	GlaxoSmithKline	Phase 1	2006-04-28	Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely given in combination with the chemotherapy agents TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest when these agents are given together and whether the combination of pazopanib with chemotherapy, helps to treat different types of cancer. Another objective is to find out how much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the agents are given. Collecting the blood samples requires that the patients remain in the vicinity of the clinic overnight on 2 occasions.
NCT00334282 ↗	Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma	Completed	GlaxoSmithKline	Phase 3	2006-04-01	To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate [complete response (CR) + partial response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.

Clinical Trial Conditions for VOTRIENT

Condition Name

Condition Name for VOTRIENT
Intervention	Trials
Stage IV Renal Cell Cancer	7
Carcinoma, Renal Cell	7
Clear Cell Renal Cell Carcinoma	7
Renal Cell Carcinoma	6

Condition MeSH

Condition MeSH for VOTRIENT
Intervention	Trials
Carcinoma	30
Carcinoma, Renal Cell	27
Sarcoma	20
Neoplasms	12

Clinical Trial Locations for VOTRIENT

Trials by Country

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−

Trials by Country for VOTRIENT
Location	Trials
United States	543
Germany	57
Italy	41
Canada	39
United Kingdom	18

Trials by US State

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−

Trials by US State for VOTRIENT
Location	Trials
Texas	30
California	23
Illinois	20
Minnesota	20
Michigan	20

Clinical Trial Progress for VOTRIENT

Clinical Trial Phase

Clinical Trial Phase for VOTRIENT
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for VOTRIENT
Clinical Trial Phase	Trials
Completed	61
Terminated	19
Active, not recruiting	14

Clinical Trial Sponsors for VOTRIENT

Sponsor Name

Sponsor Name for VOTRIENT
Sponsor	Trials
National Cancer Institute (NCI)	35
GlaxoSmithKline	34
Novartis	14

Sponsor Type

Sponsor Type for VOTRIENT
Sponsor	Trials
Other	107
Industry	74
NIH	35

Votrient (Pazopanib): Clinical Trials, Market Analysis, and Projections

Introduction

Votrient, also known as pazopanib, is a targeted therapy used in the treatment of advanced renal cell carcinoma (RCC), a form of kidney cancer. This article will delve into the latest clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Phase 2 Trial for Metastatic ccRCC

A recent phase 2 study presented at the 2024 European Society for Medical Oncology Congress has shown promising results for the combination of pazopanib and bevacizumab in patients with treatment-naïve metastatic clear cell renal cell carcinoma (ccRCC). The study involved 51 patients who received pazopanib 800 mg daily on days 1 through 28, and bevacizumab 10 mg/kg on days 36 and 50 of a 10-week cycle.

• Efficacy: The median progression-free survival (PFS) was 22.1 months, more than double the PFS seen with pazopanib alone in previous trials (11.1 months)[1].
• Response Rate: The overall response rate (ORR) was 54.9%, with a stable disease rate of 43.1%, resulting in a clinical benefit rate (CBR) of 98%[1].
• Safety: The regimen was generally well-tolerated, with common adverse events including diarrhea, hypertension, fatigue, and nausea. Grade 3 or 4 adverse events included hypertension, ALT elevation, and AST elevation[1].

FDA Approval and Historical Context

Votrient was approved by the FDA in 2009 for the treatment of advanced RCC based on a phase III clinical trial that showed it reduced the risk of tumor progression or death by 54% compared to placebo[3].

Market Analysis

Global Market Size and Growth

The global pazopanib market is expected to grow significantly over the next few years. According to market research, the pazopanib market is projected to reach USD xx.x billion by 2031, with a compound annual growth rate (CAGR) of xx.x percent from 2024 to 2031[5].

Key Players and Market Share

The market is dominated by key players such as GlaxoSmithKline (GSK), the original developer and marketer of Votrient. Other companies, including Novartis, also play a role in the market, although GSK remains a major player due to its long-standing presence and FDA approval[5].

Regional Analysis

The market for pazopanib is expected to be driven by regions with high incidence rates of renal cell carcinoma. The United States, Europe, and Asia-Pacific regions are anticipated to be significant contributors to the market growth due to their large patient populations and advanced healthcare systems[2].

Market Projections

Growth Drivers

Several factors are driving the growth of the pazopanib market:

• Increasing Incidence of RCC: The rising number of kidney cancer cases globally is a significant driver.
• Advancements in Targeted Therapies: The efficacy of pazopanib as a targeted therapy continues to attract patients and healthcare providers.
• Expanding Treatment Options: The combination of pazopanib with other drugs, such as bevacizumab, is expanding treatment options and improving outcomes[1][3].

Market Restraints

Despite the growth potential, there are several restraints to consider:

• Side Effects and Toxicities: Common adverse events and the potential for severe toxicities can limit patient tolerance and compliance.
• Cost and Accessibility: The high cost of targeted therapies can be a barrier to access, especially in regions with limited healthcare resources.
• Competition from Other Therapies: The emergence of new immunotherapies and other targeted treatments can compete with pazopanib for market share[1][3].

Additional Uses and Research

Potential Use in Hereditary Hemorrhagic Telangiectasia (HHT)

While pazopanib is not currently approved for Hereditary Hemorrhagic Telangiectasia (HHT), there are ongoing efforts by organizations like Cure HHT to explore its potential in this area. Despite initial setbacks due to lack of interest from pharmaceutical companies, Cure HHT has secured funding to continue clinical trials and aims to seek FDA approval for this indication[4].

Key Takeaways

• Clinical Efficacy: The combination of pazopanib and bevacizumab shows promising efficacy in treating metastatic ccRCC.
• Market Growth: The global pazopanib market is expected to grow significantly, driven by increasing incidence of RCC and advancements in targeted therapies.
• Challenges: Side effects, cost, and competition from other therapies are key restraints to market growth.
• Future Potential: Ongoing research into additional indications, such as HHT, could expand the market further.

FAQs

What is the current clinical status of pazopanib in treating metastatic ccRCC?

Pazopanib, when combined with bevacizumab, has shown promising efficacy in a phase 2 trial for treatment-naïve metastatic clear cell renal cell carcinoma, with a median PFS of 22.1 months[1].

What are the common adverse events associated with pazopanib?

Common adverse events include diarrhea, hypertension, fatigue, and nausea. Grade 3 or 4 adverse events include hypertension, ALT elevation, and AST elevation[1].

What is the projected market size for pazopanib by 2031?

The global pazopanib market is expected to reach USD xx.x billion by 2031, with a CAGR of xx.x percent from 2024 to 2031[5].

Who are the key players in the pazopanib market?

GlaxoSmithKline (GSK) is the primary player, with other companies like Novartis also involved in the market[5].

Is pazopanib being explored for other indications?

Yes, pazopanib is being explored for its potential use in Hereditary Hemorrhagic Telangiectasia (HHT) by organizations like Cure HHT[4].

What are the main drivers of the pazopanib market growth?

The main drivers include the increasing incidence of RCC, advancements in targeted therapies, and expanding treatment options[1][3].

References

1. Urology Times: "Pazopanib plus bevacizumab shows promising phase 2 efficacy in ccRCC" - September 25, 2024.
2. Cognitive Market Research: "Global Pazopanib Market Report 2024 Edition" - 2024.
3. GlaxoSmithKline: "FDA approves GlaxoSmithKline's Votrient™ for advanced renal cell cancer" - October 19, 2009.
4. CureHHT: "Pazopanib Clinical Trial: Q&A" - September 26, 2023.
5. OpenPR: "Pazopanib Market Analysis By Top Keyplayers - Novartis, GlaxoSmithKline" - November 11, 2024.