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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR AXITINIB


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505(b)(2) Clinical Trials for Axitinib

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 NCT03571438 ↗ Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors Recruiting University Hospital, Grenoble N/A 2017-10-16 The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation of the University Hospital of Grenoble and to compare their efficacy with that of currently selected treatments in the clinic. The population targeted by the combination for use in clinical practice is patients with metastatic clear cell renal cell carcinoma. Current treatments for these patients are Sunitinib, Pazopanib and Temsirolimus.
New Combination NCT05070221 ↗ Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis Not yet recruiting Beijing Cancer Hospital Phase 1 2021-10-01 Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Axitinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00071006 ↗ AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS) Completed Pfizer Phase 2 2003-09-01 The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.
NCT00094094 ↗ Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer Completed Pfizer Phase 2 2005-02-01 This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage
NCT00219557 ↗ AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer Completed Pfizer Phase 2 2005-07-05 This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Axitinib

Condition Name

Condition Name for Axitinib
Intervention Trials
Renal Cell Carcinoma 17
Metastatic Renal Cell Carcinoma 10
Clear Cell Renal Cell Carcinoma 10
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Condition MeSH

Condition MeSH for Axitinib
Intervention Trials
Carcinoma, Renal Cell 66
Carcinoma 59
Kidney Neoplasms 12
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Clinical Trial Locations for Axitinib

Trials by Country

Trials by Country for Axitinib
Location Trials
United States 492
Japan 66
United Kingdom 39
China 38
Canada 34
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Trials by US State

Trials by US State for Axitinib
Location Trials
California 32
Texas 31
New York 26
Ohio 24
Florida 22
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Clinical Trial Progress for Axitinib

Clinical Trial Phase

Clinical Trial Phase for Axitinib
Clinical Trial Phase Trials
Phase 3 9
Phase 2/Phase 3 2
Phase 2 97
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Clinical Trial Status

Clinical Trial Status for Axitinib
Clinical Trial Phase Trials
Completed 59
Recruiting 41
Not yet recruiting 23
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Clinical Trial Sponsors for Axitinib

Sponsor Name

Sponsor Name for Axitinib
Sponsor Trials
Pfizer 76
National Cancer Institute (NCI) 14
Merck Sharp & Dohme Corp. 8
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Sponsor Type

Sponsor Type for Axitinib
Sponsor Trials
Industry 132
Other 127
NIH 14
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Axitinib: Clinical Trials, Market Analysis, and Projections

Introduction to Axitinib

Axitinib is a tyrosine kinase inhibitor that targets vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3, and is primarily used in the treatment of advanced renal cell carcinoma (RCC). Here, we will delve into the clinical trials, market analysis, and projections for this significant oncology drug.

Clinical Trials Overview

Phase 3 Trials

Axitinib has been extensively studied in several Phase 3 clinical trials. One notable trial compared axitinib to sorafenib in patients with advanced RCC who had disease progression after initial systemic therapy. This trial showed that the median progression-free survival (PFS) for patients receiving axitinib was 6.7 months, compared to 4.7 months for those receiving sorafenib[3].

In another Phase 3 trial, the AXIS study, axitinib demonstrated superior PFS compared to sorafenib, with median PFS ranging from 6.7 to 8.3 months depending on the patient population[1].

Single-Arm Clinical Trials

Single-arm clinical trials have also provided valuable insights into axitinib's efficacy. For instance, a Phase 2 single-arm trial in Japan involving patients with metastatic RCC who had failed previous cytokine-based treatment showed a median PFS of 7.1 to 15.7 months[1].

Combination Therapies

Recent clinical trials have explored the efficacy of axitinib in combination with other therapies. The combination of axitinib with pembrolizumab has shown promising results, reducing the overall risk of death by 47% compared to sunitinib alone. This combination has demonstrated improved overall survival and PFS in patients with advanced RCC[4].

Safety and Tolerability

Axitinib's safety profile has been well-documented in clinical trials. Common adverse events include hypertension, proteinuria, fatigue, and diarrhea, which are exposure-dependent. A dose reduction strategy from 5 mg to 3 mg to 2 mg twice daily is recommended to manage these side effects[3].

Pharmacokinetics

The pharmacokinetics of axitinib indicate a median plasma Tmax of 2.5 to 4.1 hours and a mean half-life of 2.5 to 6.1 hours. The mean absolute bioavailability of axitinib is 58%, and it can be administered with or without food[3].

Market Analysis

Current Market Size

The global axitinib market was valued at USD 5.42 billion in 2023 and is expected to grow significantly in the coming years. The market is projected to reach USD 10.4 billion by 2031, with a compound annual growth rate (CAGR) of 9.2% from 2024 to 2031[2].

Market Segmentation

The axitinib market is segmented based on application, product, and geographical regions. Key segments include its use as a tyrosine kinase inhibitor, its application in renal cell carcinoma and advanced renal cell carcinoma, and its presence in regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[2].

Growth Drivers

Several factors are driving the growth of the axitinib market:

  • Established Use in RCC: Axitinib's efficacy as a first-line and second-line treatment for advanced RCC is a significant driver.
  • Expanding Indications: Ongoing clinical trials evaluating axitinib in other cancers, such as hepatocellular carcinoma (HCC) and lung cancer, are expanding its therapeutic applications[2][5].
  • Rising Cancer Prevalence: The increasing global burden of cancer and the growing adoption of targeted therapies with fewer side effects compared to traditional chemotherapy are driving market growth.
  • Government Support and Combination Therapies: Growing government funding for cancer research and the development of combination therapies involving axitinib are creating a positive market outlook[2].

Market Projections

Future Market Value

The global axitinib market is expected to experience robust growth, driven by its expanding therapeutic applications and increasing adoption. By 2031, the market is projected to reach USD 10.4 billion, reflecting a strong growth trajectory[2].

Investment Opportunities

The axitinib market presents significant investment opportunities, particularly in:

  • Research and Development (R&D): Funding for ongoing and future clinical trials to explore new indications and combination therapies.
  • Strategic Partnerships: Collaborations between pharmaceutical companies and research institutions to enhance axitinib's therapeutic potential.
  • Innovations in Formulations and Delivery Methods: Development of novel formulations, such as extended-release formulations, and innovative delivery methods to optimize patient compliance and treatment efficacy[5].

Key Takeaways

  • Axitinib has demonstrated superior PFS compared to other treatments in clinical trials for advanced RCC.
  • The drug's safety profile includes manageable side effects such as hypertension and proteinuria.
  • The global axitinib market is projected to grow significantly, reaching USD 10.4 billion by 2031.
  • Expanding indications, rising cancer prevalence, and government support for cancer research are key drivers of market growth.
  • Investment opportunities abound in R&D, strategic partnerships, and innovations in drug formulations and delivery methods.

FAQs

What is the primary use of axitinib in oncology?

Axitinib is primarily used in the treatment of advanced renal cell carcinoma (RCC).

What are the common side effects of axitinib?

Common side effects include hypertension, proteinuria, fatigue, and diarrhea, which are exposure-dependent and can be managed with dose reductions.

How does axitinib compare to other treatments in terms of PFS?

Axitinib has shown superior PFS compared to sorafenib and other treatments in clinical trials for advanced RCC.

What is the projected market value of axitinib by 2031?

The global axitinib market is projected to reach USD 10.4 billion by 2031, growing at a CAGR of 9.2% from 2024 to 2031.

What are the key drivers of the axitinib market growth?

Key drivers include its established use in RCC, expanding indications, rising cancer prevalence, and growing government support for cancer research and development of combination therapies.

Sources

  1. MDPI: Axitinib after Treatment Failure with Sunitinib or Cytokines in ... - MDPI
  2. Market Research Intellect: Axitinib Market Size and Projections - Market Research Intellect
  3. FDA: 202324Orig1s000 - accessdata.fda.gov
  4. INLYTA: INLYTA® (axitinib) with pembrolizumab Clinical Trial Results
  5. Market Research Intellect: Axitinib Market Size And Projection - Market Research Intellect

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