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Tyrosine Kinase Inhibitor

Cabozantinib for Endometrial Cancer

Phase 2

Waitlist Available

Led By Neesha Dhani

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have measurable disease and radiographic evidence of disease progression following the most recent line of treatment

Patients must have histologically or cytologically confirmed metastatic endometrial cancer with eligible histologies

Must not have

Presence of certain medical conditions such as uncontrolled cardiovascular disorders, gastrointestinal disorders, significant intercurrent illness, and history of major surgery

Pregnant or breastfeeding women, and known HIV-positive patients on combination antiretroviral therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from start of treatment to time of death, every 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies cabozantinib s-malate for endometrial cancer. Cabozantinib s-malate may stop tumor growth by blocking enzymes and blood flow to the tumor.

Who is the study for?

This trial is for women with certain types of advanced endometrial cancer that has returned or spread. Participants must have a life expectancy over 3 months, meet specific health criteria, not be pregnant, and agree to use birth control. They should not have had recent cancer treatments or surgeries and cannot have taken cabozantinib before.

What is being tested?

The study tests how well the drug cabozantinib s-malate works on recurrent or metastatic endometrial cancer by inhibiting tumor growth enzymes and cutting off blood supply to tumors. It includes lab biomarker analysis and pharmacological studies to monitor effects.

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, weight loss due to decreased appetite, abnormal liver enzyme levels, voice changes and possibly other unknown risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has grown or spread after my last treatment.

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My endometrial cancer has spread and is confirmed by lab tests.

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I can take care of myself but might not be able to do heavy physical work.

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I have had one round of chemotherapy or hormone therapy for my cancer that has spread or come back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled heart, stomach issues, or other major health problems.

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I am not pregnant, breastfeeding, or HIV-positive on antiretroviral therapy.

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I have been treated with cabozantinib before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from start of treatment to time of death, every 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from start of treatment to time of death, every 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of treatment to time of death, every 6 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

Response Rate

Secondary study objectives

Number of Participants With Archival Specimens That Had C-met Amplification or Mutation

Overall Survival

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 s-malate)Experimental Treatment3 Interventions

Patients receive 60 mg cabozantinib s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib S-malate

2013

Completed Phase 2

~590

0 / 7Eligibility criteria met