CLINICAL TRIALS PROFILE FOR SUNITINIB MALATE

All Clinical Trials for sunitinib malate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00137436 ↗	Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer	Completed	Pfizer	Phase 1/Phase 2	2005-10-01	This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
NCT00246571 ↗	Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer	Completed	Pfizer	Phase 2	2006-01-01	The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
NCT00265798 ↗	Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2005-09-14	This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib 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.
NCT00267748 ↗	Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)	Completed	Pfizer	Phase 2	2005-12-01	This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
NCT00326898 ↗	Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery	Completed	Cancer and Leukemia Group B	Phase 3	2006-04-24	This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate 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. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.

Clinical Trial Conditions for sunitinib malate

Condition Name

Condition Name for sunitinib malate
Intervention	Trials
Kidney Cancer	21
Stage IV Renal Cell Cancer	13
Renal Cell Carcinoma	11
Stage III Renal Cell Cancer	11

Condition MeSH

Condition MeSH for sunitinib malate
Intervention	Trials
Carcinoma, Renal Cell	55
Carcinoma	44
Kidney Neoplasms	30
Breast Neoplasms	14

Clinical Trial Locations for sunitinib malate

Trials by Country

Trials by Country for sunitinib malate
Location	Trials
United States	737
Canada	59
Japan	34
Korea, Republic of	31
United Kingdom	29

Trials by US State

Trials by US State for sunitinib malate
Location	Trials
Texas	41
California	36
New York	36
Ohio	32
Illinois	27

Clinical Trial Progress for sunitinib malate

Clinical Trial Phase

Clinical Trial Phase for sunitinib malate
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	9
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for sunitinib malate
Clinical Trial Phase	Trials
Completed	107
Terminated	37
Active, not recruiting	11

Clinical Trial Sponsors for sunitinib malate

Sponsor Name

Sponsor Name for sunitinib malate
Sponsor	Trials
National Cancer Institute (NCI)	70
Pfizer	65
M.D. Anderson Cancer Center	13

Sponsor Type

Sponsor Type for sunitinib malate
Sponsor	Trials
Other	115
Industry	90
NIH	73

Sunitinib malate Market Analysis and Financial Projection

Sunitinib Malate: Clinical Trials, Market Analysis, and Projections

Introduction

Sunitinib malate, marketed as Sutent by Pfizer Inc., is a small-molecule medicine that has revolutionized the treatment of various types of cancer. This article delves into the current clinical trials, market analysis, and future projections for this potent anticancer drug.

Clinical Trials Update

Ongoing and Completed Trials

Sunitinib malate has been extensively studied in various clinical trials to evaluate its efficacy and safety in different cancer types. One notable trial is the randomized phase III trial (NCT00326898) that compared sunitinib malate to sorafenib tosylate or placebo in treating patients with kidney cancer that had been removed by surgery. This trial aimed to determine whether sunitinib malate could prevent the recurrence of kidney cancer post-surgery by targeting any remaining tumor cells[1].

Current Research Focus

Currently, sunitinib malate is being studied in combination with other therapies, such as checkpoint inhibitors, to enhance its effectiveness in treating metastatic cancers. These ongoing clinical trials are showing promising results in extending patient survival rates and improving treatment outcomes[5].

New Indications and Formulations

Ongoing research is also focused on identifying new indications for sunitinib malate and developing novel formulations and combination therapies. This includes exploring its use in pancreatic neuroendocrine tumors, gastrointestinal stromal tumors (GIST), and other types of cancer where it has shown significant antineoplastic activity[3][4].

Market Analysis

Market Size and Growth

The global sunitinib malate market is projected to experience significant growth over the next decade. According to market forecasts, the market size is expected to reach around $265 million by 2030, growing at a CAGR of 12% from 2024 to 2030[2]. Another report estimates the market size to be worth around $378 million by 2033, growing at a CAGR of 12.1% from 2024 to 2033[3].

Regional Analysis

North America holds the largest market share due to high cancer prevalence, favorable reimbursement policies, and a strong pharmaceutical infrastructure. Europe follows closely, driven by advancements in cancer treatment and clinical research. Emerging markets in the Asia-Pacific region are also witnessing rapid growth in demand, fueled by increasing cancer rates and improving healthcare access[3][5].

Market Segments

The largest segment for sunitinib malate remains renal cell carcinoma (RCC), where it is used as a first-line treatment for advanced and metastatic forms. It is also gaining traction in the GIST treatment market, particularly among patients who do not respond to imatinib. Pancreatic neuroendocrine tumors occupy a significant share, with sunitinib malate being a key treatment option for these conditions[3][5].

Market Drivers and Trends

Rising Incidence of Cancer

The increasing incidence of renal cell carcinoma, GIST, and pancreatic neuroendocrine tumors is a major driver of the sunitinib malate market. As cancer rates rise globally, the demand for effective targeted therapies like sunitinib malate is also increasing[3][5].

Advancements in Precision Oncology

The shift towards personalized and targeted therapies is a significant trend in the sunitinib malate market. Sunitinib malate's ability to selectively target molecular pathways associated with cancer makes it a prominent player in the precision medicine era[3][5].

Strategic Collaborations and Partnerships

The market has seen an increase in strategic collaborations and partnerships among pharmaceutical companies, research institutions, and healthcare providers. These alliances aim to develop innovative formulations, combination therapies, and expanded indications for sunitinib malate, fostering a competitive and dynamic market landscape[3][5].

Challenges and Opportunities

Drug Resistance and Side Effects

Despite its efficacy, sunitinib malate faces challenges such as drug resistance and side effects like hypertension and fatigue. These issues have spurred further research into improving the safety profile of the drug without compromising its effectiveness[5].

Emerging Markets and New Indications

There is a significant opportunity for expanding sunitinib malate into emerging markets where the cancer burden is growing rapidly. Additionally, ongoing clinical trials and the identification of new indications are expected to expand the market potential for this drug[3][5].

Pipeline Development

The development of novel formulations and combination therapies using sunitinib malate presents an immense opportunity for market growth. As new therapeutic areas are identified and granted regulatory approvals, the market potential for sunitinib malate is expected to increase further[3].

Key Takeaways

• Market Growth: The global sunitinib malate market is projected to grow significantly, reaching $265 million by 2030 or $378 million by 2033.
• Clinical Trials: Ongoing trials are exploring the use of sunitinib malate in combination with other therapies to enhance its effectiveness.
• Regional Analysis: North America and Europe are the leading regions, with emerging markets in Asia-Pacific showing rapid growth.
• Market Drivers: Rising cancer incidence, advancements in precision oncology, and strategic collaborations are key drivers.
• Challenges and Opportunities: Addressing drug resistance and side effects, and expanding into emerging markets and new indications are critical.

FAQs

What is sunitinib malate used for?

Sunitinib malate is used to treat adults with gastrointestinal stromal tumor (GIST), pancreatic neuroendocrine tumors, and renal cell carcinoma (RCC)[4].

What are the main drivers of the sunitinib malate market?

The main drivers include the rising incidence of cancer, advancements in precision oncology, and strategic collaborations among pharmaceutical companies and research institutions[3][5].

What are the challenges faced by the sunitinib malate market?

Challenges include drug resistance, side effects like hypertension and fatigue, and the high cost of research and development[2][5].

Which regions are leading the sunitinib malate market?

North America holds the largest market share, followed by Europe, with emerging markets in the Asia-Pacific region showing significant growth[3][5].

What are the future projections for the sunitinib malate market?

The market is projected to reach $265 million by 2030 or $378 million by 2033, growing at a CAGR of 12% to 12.1% during the forecast period[2][3].

Sources

1. ClinicalTrials.gov: Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery.
2. IndustryARC: Sunitinib Malate Market Size, Share | Industry Trend & Forecast 2030.
3. Market.us: Sunitinib Malate Market Size, Share, Outlook | CAGR of 12.1%.
4. National Cancer Institute: Sunitinib Malate.
5. GlobeNewswire: Sunitinib Malate Global Strategic Business Report 2024-2030.