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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of treatment to time of death, every 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Response Rate
Secondary outcome measures
Number of Participants With Archival Specimens That Had C-met Amplification or Mutation
Overall Survival

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
~470

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,261 Total Patients Enrolled
17 Trials studying Endometrial Carcinoma
8,748 Patients Enrolled for Endometrial Carcinoma
Neesha DhaniPrincipal InvestigatorUniversity Health Network-Princess Margaret Hospital

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01935934 — Phase 2
Endometrial Carcinoma Research Study Groups: Treatment (cabozantinib s-malate)
Endometrial Carcinoma Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT01935934 — Phase 2
Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01935934 — Phase 2
~8 spots leftby Jun 2025
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