Neoadjuvant Cabozantinib for Kidney Cancer

Overseen By Viraj Master, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Anticoagulants, Platelet inhibitors

Disqualifiers: Metastatic disease, Brain metastases, Cardiovascular disorders, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

22 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cabozantinib orally once daily for 12 weeks

12 weeks

Regular monitoring visits

Surgery

Participants undergo surgery after completion of cabozantinib treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

Treatment Details

Interventions

• Cabozantinib

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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+