What side effects are associated with this type of intervention?

Cabozantinib, an enzyme inhibitor used in treating adrenal cancer, can cause several side effects. Common adverse effects include increased levels of liver enzymes (alanine aminotransferase and aspartate aminotransferase), hypertension, and palmar-plantar erythrodysaesthesia. Serious treatment-related adverse events can also occur, such as significant increases in liver enzymes and hypertension. Patients undergoing this treatment should be closely monitored for these potential side effects.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically for adrenal cancer, particularly those that function through enzyme inhibition like cabozantinib. Cabozantinib itself is being studied for its efficacy in treating locally advanced or metastatic unresectable adrenocortical carcinoma by blocking enzymes necessary for tumor cell growth. Other treatments for adrenal cancer may include mitotane, which is FDA-approved and works by inhibiting steroid synthesis, but it does not function through enzyme inhibition in the same way as cabozantinib.

What other types of research exist?

As of 2024, promising novel alternatives to Cabozantinib for adrenal cancer patients include selective RET inhibitors like Selpercatinib and Pralsetinib, which have shown efficacy in other RET-altered cancers. Additionally, immunotherapies such as pembrolizumab and nivolumab, which target PD-1, may offer potential benefits, especially for patients with specific genetic markers or those who have not responded to enzyme inhibition therapies.

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Tyrosine Kinase Inhibitor

Cabozantinib for Adrenocortical Cancer

Phase 2

Waitlist Available

Led By Mouhammed A Habra

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well cabozantinib works in patients with advanced adrenal cortex cancer that cannot be removed by surgery. Cabozantinib is taken by mouth and aims to stop cancer cells from growing by blocking certain enzymes they need. The trial will measure how long patients live without the cancer getting worse and other outcomes like overall survival and side effects.

Who is the study for?

This trial is for adults with advanced or metastatic adrenocortical carcinoma that can't be surgically removed. Participants must understand the study, agree to use contraception, have a certain level of physical fitness (ECOG 0-2), and not be pregnant. They should have recovered from previous treatments and have a life expectancy of at least 3 months.

What is being tested?

The trial is testing Cabozantinib's effectiveness on patients with inoperable adrenal cortex cancer that has spread. It involves monitoring how the drug affects tumor growth by blocking enzymes needed for cell growth, alongside pharmacokinetic and pharmacogenomic studies.

What are the potential side effects?

Cabozantinib may cause side effects such as fatigue, high blood pressure, hand-foot skin reactions, gastrointestinal symptoms like diarrhea and nausea, abnormal liver enzyme levels, decreased appetite and weight loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Secondary study objectives

Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE)

Overall response rate (ORR) as defined by RECIST 1.1 criteria

Overall survival (OS) as defined by RECIST 1.1 criteria

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cabozantinib)Experimental Treatment3 Interventions

Patients receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

2020

Completed Phase 2

~1760

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cabozantinib, an enzyme inhibitor, works by blocking specific enzymes that are essential for the growth and survival of tumor cells. This inhibition can prevent the proliferation of cancer cells and potentially shrink tumors. For adrenal cancer patients, this mechanism is crucial as it targets the cancer at a molecular level, offering a treatment option when the cancer is locally advanced, metastatic, and unresectable. Other common treatments for adrenal cancer may include chemotherapy and targeted therapies, which also aim to disrupt cancer cell growth through various mechanisms such as DNA damage or hormone inhibition. Understanding these mechanisms helps in selecting the most effective treatment strategy tailored to the patient's specific cancer characteristics.