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Angiogenesis inhibitor

Drug Combinations for Kidney Cancer

Phase 2
Waitlist Available
Led By Amado Zurita, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >/= 18 years
Confirmed metastatic RCC with a clear cell component
Must not have
Known hypersensitivity to any component of bevacizumab, pazopanib or everolimus
Patients must not be scheduled to receive another experimental drug while on this study. Patients are permitted to receive concomitant bisphosphonates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing six different combinations of two drugs to see which is most effective in treating metastatic kidney cancer.

Who is the study for?
Adults with metastatic renal cell carcinoma (RCC) that includes a clear cell component, who have had surgery or certain other treatments for their primary tumor. They must be able to swallow pills, not have received targeted therapy or chemotherapy for mRCC (though prior immunotherapy is okay), and agree to use birth control. People with active infections, another cancer treatment ongoing, significant heart issues, uncontrolled hypertension or diabetes, severe liver disease, brain metastases (except controlled solitary ones), coagulation disorders on certain anticoagulants are excluded.
What is being tested?
The START trial is testing six different combinations of the drugs everolimus, bevacizumab, and pazopanib in sequences to see which works best against metastatic kidney cancer. Participants will start with one drug and may switch to another as part of the sequence while researchers monitor safety and effectiveness.
What are the potential side effects?
Possible side effects include high blood pressure; bleeding; protein in urine; immune system suppression leading to increased infection risk; hypersensitivity reactions; impaired wound healing; elevated cholesterol or triglycerides levels requiring medication management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney cancer has spread and shows clear cell features.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to bevacizumab, pazopanib, or everolimus.
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I am not planning to take any experimental drugs but can take bisphosphonates while in this study.
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I do not have high levels of protein in my urine.
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I have a serious wound or fracture that is not healing.
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I am not pregnant or breastfeeding.
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I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery during the study.
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I am not taking rifampin, St. John's wort, or certain seizure medications.
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My lung function is severely impaired, with low oxygen levels or less than half the normal lung capacity.
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I do not have serious heart problems.
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My blood pressure is controlled and I have never had a hypertensive crisis.
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I have coughed up a significant amount of blood recently.
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I have a serious blood vessel condition like an aortic aneurysm.
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I have symptoms of poor blood flow in my limbs.
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I am not HIV-positive or on anti-retroviral therapy.
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I am not receiving treatment for any cancer other than kidney cancer.
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I do not have any infections that aren't responding to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Overall Treatment Failure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 6Experimental Treatment2 Interventions
Bevacizumab + possible Everolimus
Group II: Group 5Experimental Treatment1 Intervention
Bevacizumab + possible Pazopanib
Group III: Group 4Experimental Treatment2 Interventions
Everolimus + possible Pazopanib
Group IV: Group 3Experimental Treatment2 Interventions
Everolimus + possible Bevacizumab
Group V: Group 2Experimental Treatment2 Interventions
Pazopanib + possible Everolimus
Group VI: Group 1Experimental Treatment2 Interventions
Pazopanib + possible Bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Bevacizumab
2013
Completed Phase 4
~5540
Pazopanib
2012
Completed Phase 4
~1700

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,123 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,167 Total Patients Enrolled
Amado Zurita, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01217931 — Phase 2
Kidney Cancer Research Study Groups: Group 6, Group 1, Group 5, Group 2, Group 4, Group 3
Kidney Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01217931 — Phase 2
Bevacizumab (Angiogenesis inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01217931 — Phase 2
~1 spots leftby Jan 2025
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