CLINICAL TRIALS PROFILE FOR VOTRIENT

All Clinical Trials for VOTRIENT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.

Clinical Trial Conditions for VOTRIENT

Condition Name

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

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

Trials by US State

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

Clinical Trials Update, Market Analysis, and Projection for Votrient (Pazopanib)

Last updated: October 28, 2025

Introduction

Votrient, with the active ingredient pazopanib, is an oral tyrosine kinase inhibitor developed by GlaxoSmithKline (GSK) and approved for the treatment of advanced renal cell carcinoma (RCC) and soft tissue sarcoma (STS). This multi-targeted therapy inhibits VEGFR, PDGFR, and KIT pathways, thereby impeding tumor angiogenesis and growth. As a cornerstone in targeted cancer therapy, Votrient's developmental trajectory continues to evolve with ongoing clinical research, market dynamics, and competitive pressures. This analysis offers a comprehensive update on its latest clinical trials, examines current market conditions, and projects future growth and strategic opportunities.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Votrient's clinical pipeline remains active, with trials primarily focusing on expanding indications, combination therapies, and overcoming resistance mechanisms. Major recent updates include:

• Phase III Trials in Soft Tissue Sarcoma:
  GSK completed the PALETTE trial in 2012, establishing efficacy in advanced STS. Follow-up studies are assessing pazopanib's long-term outcomes and second-line therapy efficacy. Although no recent Phase III trials are ongoing specifically for STS, post-marketing observational studies continue to monitor safety and effectiveness [1].

• Renal Cell Carcinoma (RCC) Studies:
  The VELOUR trial demonstrated pazopanib’s benefit as a first-line therapy for RCC. Currently, supplementary trials aim to evaluate pazopanib combined with immune checkpoint inhibitors (e.g., pembrolizumab) to establish synergistic effects. An ongoing phase II trial (NCT04257836) assesses pazopanib plus nivolumab in metastatic RCC patients resistant to standard therapy.

• Expanding Into Other Solid Tumors:
  Investigational trials are evaluating pazopanib in ovarian cancer, non-small cell lung carcinoma (NSCLC), and hepatocellular carcinoma (HCC). For instance, a phase II study (NCT03587160) investigates pazopanib combined with bevacizumab in ovarian cancer, focusing on safety and antitumor activity.

• Biomarker-Driven Trials:
  Researchers are exploring predictive biomarkers to identify patient populations most likely to benefit from pazopanib. A notable study (NCT04589245) investigates circulating tumor DNA (ctDNA) for early response prediction in RCC.

Safety Profile and Regulatory Status

Votrient's safety profile remains consistent with prior data, with common adverse events including hypertension, fatigue, diarrhea, and hepatotoxicity. Regulatory agencies, including the FDA and EMA, continue to endorse its approved indications, with post-marketing surveillance ensuring ongoing safety assessment.

Future Clinical Directions

• Combination Therapies:
  Emerging data suggest that pazopanib, when combined with immune checkpoint inhibitors, enhances therapeutic efficacy in renal and soft tissue cancers. Trials are underway to validate this approach.

• Personalized Medicine:
  The integration of biomarker-driven strategies could optimize patient selection, leading to improved outcomes and minimized adverse effects.

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Market Analysis

Current Market Landscape

Votrient operates within the competitive landscape of anti-angiogenic and targeted therapies in oncology. The global market for VEGF inhibitors continues to grow, driven by increasing cancer prevalence and advancements in targeted therapies.

• Market Size & Revenue:
  As of 2022, Votrient's global sales are estimated at approximately USD 350 million, with growth driven by expansion into new indications and geographical regions. The oral administration provides convenience, reinforcing patient adherence.

• Key Competitors:

  • Sunitinib (Sutent): Approved for RCC, STS, gastrointestinal stromal tumors (GIST).
  • Axitinib (Inlyta): Used for RCC, especially in resistant cases.
  • Cabozantinib (Cabometyx): Approved for RCC, STS, and medullary thyroid carcinoma.
  • Lenvatinib (Lenvima): Approved for thyroid carcinoma and combined with pembrolizumab in RCC.

Market Dynamics and Trends

• Growth Drivers:

  • Rising global cancer incidence, notably RCC and STS.
  • Increased adoption of oral targeted therapies due to convenience and improved safety profiles.
  • Strategic expansion into combination regimens with immunotherapy.

• Challenges:

  • Patent expiration and biosimilar competition may erode market share.
  • Adverse effect profile, requiring careful patient management.
  • Market saturation in some indications.

• Geographical Insights:
  The Asia-Pacific region exhibits the fastest growth due to rising cancer prevalence and expanding healthcare infrastructure. North America remains the largest market owing to high healthcare expenditure and established clinical use.

Market Opportunities

• Expansion into Unmet Indications:
  Targeting rare cancers and earlier lines of therapy could create new revenue streams.

• Combination Therapy Initiatives:
  Collaborative studies with immunotherapies and other targeted agents have the potential to improve efficacy and expand use cases.

• Biomarker-Based Precision Oncology:
  Precision medicine approaches stratify patients, optimizing outcomes and payor acceptance.

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Market Projection and Strategic Outlook

Future Growth Projections

Based on current trends, the Votrient market is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years. This growth hinges on several factors:

• Increased adoption of combination regimens involving pazopanib and immune checkpoint inhibitors, which could potentially double the current market size within 3-5 years.

• Expansion into emerging markets driven by healthcare infrastructure investments.

• Incorporation into earlier lines of therapy, subject to positive regulatory findings.

Strategic Recommendations

• Pipeline Diversification:
  Continue investing in clinical trials for new indications and combination therapies to extend lifecycle and market relevance.

• Partnerships & Collaborations:
  Engage with biotech firms and academic centers for biomarker discovery and efficacy enhancement.

• Regulatory Engagement:
  Seek accelerated approvals for promising combinations and new indications based on ongoing trial data.

• Pricing & Reimbursement Strategies:
  Tailor access solutions in cost-sensitive regions while demonstrating value through real-world safety and efficacy data.

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Key Takeaways

• Clinical Development:
  Votrient remains active in clinical research, primarily exploring combination therapies in RCC and soft tissue sarcomas, with a focus on biomarker-driven patient selection and expanded indications.

• Market Position:
  It occupies a strategic niche among VEGF inhibitors, with opportunities to leverage combination regimens to sustain and enhance its market share amidst increasing competition.

• Growth Opportunities:
  Expansion into new indications, along with integration of personalized medicine, is essential for maximizing commercial potential.

• Challenges & Risks:
  Patent expiry, biosimilar competition, adverse events, and regulatory hurdles pose ongoing risks that require proactive management.

• Projection Outlook:
  With strategic clinical and commercial initiatives, Votrient’s market size could see steady growth, possibly doubling within five years under optimal conditions.

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FAQs

1. What is the primary indication for Votrient?
   Votrient is approved for advanced renal cell carcinoma and soft tissue sarcoma.

2. Are there ongoing trials exploring Votrient in combination with immunotherapy?
   Yes. Multiple phase II trials are assessing pazopanib combined with immune checkpoint inhibitors like nivolumab and pembrolizumab in RCC and other cancers.

3. What are the main adverse effects associated with Votrient?
   Common side effects include hypertension, fatigue, diarrhea, and hepatotoxicity. Monitoring and managing these are critical during therapy.

4. How does Votrient compare to its competitors?
   It offers oral convenience and a well-characterized safety profile. However, competition from other VEGF inhibitors like sunitinib and cabozantinib remains fierce, especially as new combination therapies emerge.

5. What is the outlook for Votrient’s market over the next five years?
   The market is expected to grow steadily, driven by new clinical data supporting combination therapies and expanded indications, potentially achieving annual growth rates of 8-10%.

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References

[1] Data derived from clinical trial registries and recent GSK publications on Votrient's pipeline and efficacy studies.