Neoadjuvant Cabozantinib for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Mehmet Asim Bilen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II clinical trial studies how well cabozantinib works in treating patients with kidney cancer before surgery. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Mehmet Asim Bilen, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults with advanced kidney cancer that hasn't spread elsewhere. They should be fit enough for daily activities (ECOG ≤ 1), have good organ function, and not have had cancer treatment in the last 5 years. Participants must agree to use contraception and not be pregnant or breastfeeding.

Inclusion Criteria

I am not pregnant and meet the specific criteria for women of childbearing age.

Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

I haven't had cancer treatment like hormonal, chemotherapy, or immunotherapy in the last 5 years.

Exclusion Criteria

There is proof of cancer spreading to other parts of the body on the images taken before starting the treatment.

I haven't had major surgery recently.

I have received treatments like chemotherapy for kidney cancer.

Treatment Details

Interventions

• Cabozantinib (Tyrosine Kinase Inhibitor)

Trial Overview The study tests Cabozantinib's effectiveness when given before surgery to patients with locally advanced kidney cancer. It aims to see if this drug can halt tumor growth by blocking enzymes needed for cell proliferation.

Participant Groups

Group I: Treatment (cabozantinib) Experimental Treatment 1 Intervention

Patients receive cabozantinib orally once daily for 12 weeks in the absence of disease progression or unacceptable toxicity. The assigned starting dose for cabozantinib is 60 mg/day. Two dose reduction levels of cabozantinib are permitted

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School