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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
Various hematologic, hepatic, and renal function requirements
Patients must have measurable disease and radiographic evidence of disease progression following the most recent line of treatment
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 blood, liver, and kidney functions meet the required levels.
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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
13,609 Previous Clinical Trials
40,915,544 Total Patients Enrolled
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 Adenocarcinoma Research Study Groups: Treatment (cabozantinib s-malate)
Endometrial Adenocarcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there more than one location in this city where this research is taking place?

"To limit the burden of travel on participants, it is advisable to select a clinical trial site nearest to your location. Out of the 20 active sites, there are locations in South Pasadena, Indianapolis and Edmonton among others."

Answered by AI

What are the primary purposes of Cabozantinib S-malate?

"While cabozantinib S-malate is most commonly used as a second line of defense against anti-vegf, it has also been shown to be effective in the treatment of advanced renal cell carcinoma (arcc), adrenal medulla, and high risk patients."

Answered by AI

What is unique about this clinical trial?

"Since 2012, there has been an uptick in research concerning Cabozantinib S-malate. 86 patients were studied initially in 2012 under the auspices of Exelixis. The data from that first Phase 2 trial was promising and resulted in drug approval. As it stands, there are 116 ongoing trials for this medication across 1375 cities and 46 countries."

Answered by AI

How many people are participating in this research project?

"Unfortunately, this particular trial is not presently recruiting patients. Although, it's important to note that the study was updated as recently as October 15th of this year. There are presently 4254 clinical trials searching for participants with malignant neoplasms and 116 studies involving Cabozantinib S-malate are also admitting patients."

Answered by AI

Are people currently enrolling in this clinical trial?

"Unfortunately, this particular clinical trial is no longer looking for patients. The study was first posted on April 29th 2013 and received its last update October 15th 2022. However, there are 4254 other trials currently recruiting participants with malignant neoplasms and 116 studies for Cabozantinib S-malate that are still admitting patients."

Answered by AI

What is the regulatory status of Cabozantinib S-malate?

"Because this is a Phase 2 trial, there is only data supporting Cabozantinib S-malate's safety but not efficacy. We scored it a 2."

Answered by AI

What is the existing research on Cabozantinib S-malate?

"116 studies are currently underway to research Cabozantinib S-malate with 13 of those in the third stage of clinical trials. The majority of these trials taking place Cordoba and Calabria, but there are 7151 total locations spread out across researching this medication."

Answered by AI
~9 spots leftby Mar 2025