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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR CABOZANTINIB S-MALATE


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All Clinical Trials for Cabozantinib S-malate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01708954 ↗ Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer Active, not recruiting National Cancer Institute (NCI) Phase 2 2013-02-13 This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.
NCT01709435 ↗ Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Completed National Cancer Institute (NCI) Phase 1 2012-11-14 This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01716715 ↗ Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer Completed National Cancer Institute (NCI) Phase 2 2012-11-06 This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.
NCT01811212 ↗ Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Completed Exelixis Phase 2 2013-05-08 This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.
NCT01811212 ↗ Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Completed National Cancer Institute (NCI) Phase 2 2013-05-08 This phase II trial studies how well cabozantinib-s-malate works in treating patients with thyroid cancer that does not respond to treatment. Cabozantinib-s-malate may stop the growth of thyroid cancer by blocking some of the enzymes needed for cell growth. Cabozantinib-s-malate may also stop the growth of thyroid cancer by blocking blood flow to the tumor.
NCT01812668 ↗ Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer Completed United States Department of Defense N/A 2013-03-01 This pilot clinical trial studies cabozantinib-s-malate in treating patients with hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
NCT01812668 ↗ Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer Completed Barbara Ann Karmanos Cancer Institute N/A 2013-03-01 This pilot clinical trial studies cabozantinib-s-malate in treating patients with hormone-resistant metastatic prostate cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cabozantinib S-malate

Condition Name

Condition Name for Cabozantinib S-malate
Intervention Trials
Stage IV Renal Cell Cancer AJCC v8 6
Recurrent Malignant Solid Neoplasm 4
Metastatic Renal Cell Carcinoma 4
Chromophobe Renal Cell Carcinoma 3
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Condition MeSH

Condition MeSH for Cabozantinib S-malate
Intervention Trials
Carcinoma 28
Carcinoma, Renal Cell 10
Neoplasms 8
Carcinoma, Medullary 7
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Clinical Trial Locations for Cabozantinib S-malate

Trials by Country

Trials by Country for Cabozantinib S-malate
Location Trials
United States 574
Canada 14
Puerto Rico 1
France 1
Guam 1
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Trials by US State

Trials by US State for Cabozantinib S-malate
Location Trials
California 22
Pennsylvania 20
Ohio 20
Illinois 19
New York 18
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Clinical Trial Progress for Cabozantinib S-malate

Clinical Trial Phase

Clinical Trial Phase for Cabozantinib S-malate
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 2
Phase 2 28
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Clinical Trial Status

Clinical Trial Status for Cabozantinib S-malate
Clinical Trial Phase Trials
Recruiting 12
Active, not recruiting 12
Not yet recruiting 9
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Clinical Trial Sponsors for Cabozantinib S-malate

Sponsor Name

Sponsor Name for Cabozantinib S-malate
Sponsor Trials
National Cancer Institute (NCI) 39
Exelixis 6
M.D. Anderson Cancer Center 3
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Sponsor Type

Sponsor Type for Cabozantinib S-malate
Sponsor Trials
NIH 39
Other 16
Industry 6
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Cabozantinib S-Malate: Clinical Trials, Market Analysis, and Projections

Introduction

Cabozantinib S-Malate, known by its trade names Cometriq and Cabometyx, is a small molecule inhibitor of multiple receptor tyrosine kinases, including MET, VEGFR2, RET, KIT, and FLT3. This drug has been extensively studied and is approved for several types of cancer. Here, we will delve into the current clinical trials, market analysis, and future projections for cabozantinib S-malate.

Clinical Trials Overview

Current and Ongoing Trials

Cabozantinib S-malate is being investigated in various clinical trials across different cancer types.

Pediatric and Young Adult Patients

A phase II trial is ongoing to evaluate the efficacy of cabozantinib S-malate in treating younger patients with sarcomas, Wilms tumor, or other rare tumors. This trial aims to determine the objective response rate and disease control rate in these patients, as well as to assess the drug's related toxicities and pharmacokinetics[1].

Recurrent Head and Neck Squamous Cell Carcinoma

Cabozantinib S-malate is in Phase II clinical development for the treatment of recurrent head and neck squamous cell carcinoma. According to GlobalData, Phase II drugs for this indication have a 33% phase transition success rate, indicating the potential for this drug to move into Phase III trials[2].

Advanced Pancreatic and Carcinoid Tumors

A phase III trial is studying cabozantinib S-malate compared to placebo in patients with advanced pancreatic neuroendocrine tumors (NET) and carcinoid tumors. The primary objectives include determining whether cabozantinib can improve progression-free survival (PFS) and overall survival (OS) in these patients[4].

Efficacy and Safety

Key Clinical Trial Results

In a registrational trial (XL184-301) for patients with progressive, unresectable locally advanced or metastatic medullary thyroid cancer (MTC), cabozantinib demonstrated a significant improvement in PFS compared to placebo. The median PFS was 11.2 months for the cabozantinib arm versus 4.0 months for the placebo arm. The objective response rate was 27.9% for cabozantinib-treated patients, with no responses observed in the placebo group[3].

Common Adverse Events

The most commonly reported adverse events associated with cabozantinib include diarrhea, palmar-plantar erythrodysesthesia syndrome, weight decrease, decreased appetite, nausea, fatigue, dysgeusia, hair color changes, hypertension, stomatitis, constipation, vomiting, mucosal inflammation, asthenia, and dysphonia. Dose modifications due to adverse events were frequent, with 86.4% of patients in the cabozantinib arm experiencing at least one dose modification[3].

Market Analysis

Market Size and Growth

The United States thyroid cancer drugs market, which includes cabozantinib S-malate, was estimated at USD 120.32 million in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.52% to reach USD 207.72 million by 2027. This growth is driven by increasing incidence rates of thyroid cancer and the effectiveness of targeted therapies like cabozantinib S-malate[5].

Competitive Landscape

Cabozantinib S-malate competes with other targeted therapies such as lenvatinib, vandetanib, and caprelsa in the thyroid cancer market. Exelixis, the developer of cabozantinib S-malate, also markets Cabometyx for advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC), expanding its presence in the oncology market[2][5].

Projections and Future Outlook

Expanding Indications

Cabozantinib S-malate is under development for several additional cancer types, including pancreatic ductal adenocarcinoma, metastatic cervical cancer, metastatic castration-resistant prostate cancer (mCRPC), clear cell renal cell carcinoma, and others. Successful outcomes in these trials could significantly expand its market reach[2].

Likelihood of Approval

GlobalData's analysis indicates that cabozantinib S-malate has a favorable likelihood of approval for new indications, given its strong performance in current trials and the company's experience in navigating the regulatory landscape. The drug's phase transition success rate is closely monitored, and positive results could lead to further approvals[2].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including delays in clinical trials and changes in consumer behavior. However, the demand for effective cancer treatments has remained robust, and cabozantinib S-malate's market growth is expected to continue despite these challenges[5].

Key Takeaways

  • Clinical Trials: Cabozantinib S-malate is being studied in various clinical trials for different cancer types, including sarcomas, head and neck squamous cell carcinoma, and pancreatic NET.
  • Efficacy and Safety: The drug has shown significant improvements in PFS and objective response rates in several trials, though it is associated with notable adverse events.
  • Market Analysis: The market for thyroid cancer drugs, including cabozantinib S-malate, is projected to grow at a CAGR of 9.52% until 2027.
  • Future Outlook: Cabozantinib S-malate has a strong potential for expanded indications and continued market growth, driven by its efficacy and the company's strategic development plans.

FAQs

What is cabozantinib S-malate used for?

Cabozantinib S-malate is used for the treatment of various types of cancer, including medullary thyroid cancer, advanced renal cell carcinoma, and hepatocellular carcinoma.

What are the common adverse events associated with cabozantinib S-malate?

Common adverse events include diarrhea, palmar-plantar erythrodysesthesia syndrome, weight decrease, decreased appetite, nausea, fatigue, and others.

What is the current market size for thyroid cancer drugs in the United States?

The market size was estimated at USD 120.32 million in 2021 and is projected to reach USD 207.72 million by 2027.

Is cabozantinib S-malate under development for other cancer types?

Yes, it is being developed for several other cancer types, including pancreatic ductal adenocarcinoma, metastatic cervical cancer, and metastatic castration-resistant prostate cancer.

How has COVID-19 impacted the development and market of cabozantinib S-malate?

COVID-19 has caused delays in clinical trials but has not significantly impacted the demand for effective cancer treatments like cabozantinib S-malate.

Sources

  1. ClinicalTrials.gov: Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors.
  2. Pharmaceutical Technology: Cabozantinib s-malate by Exelixis for Recurrent Head And Neck Squamous Cell Carcinoma.
  3. FDA: 203756Orig1s000 - Clinical Pharmacology Review - Cabozantinib.
  4. ClinicalTrials.gov: Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine Tumors.
  5. Business Wire: United States Thyroid Cancer Drugs Market Research Report 2022.

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