180 Participants Needed

Drug Combinations for Kidney Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: Lipid lowering
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take certain drugs like rifampin, St. John's wort, or specific antiepileptic drugs during the study. It's best to discuss your current medications with the trial team.

Is the drug combination including Pazopanib safe for humans?

Pazopanib, also known as Votrient, is generally well tolerated in humans, but it can cause side effects like abnormal liver function tests and potential drug interactions. It is important to monitor for these side effects during treatment.12345

How is the drug combination of Bevacizumab, Everolimus, and Pazopanib unique for kidney cancer?

This drug combination is unique because it combines Bevacizumab, which inhibits blood vessel growth in tumors, with Everolimus, an mTOR inhibitor that blocks cancer cell growth, and Pazopanib, a multikinase inhibitor targeting several pathways involved in cancer progression. This multi-targeted approach may offer a broader attack on kidney cancer compared to single-agent therapies.16789

What data supports the effectiveness of the drug combinations for kidney cancer?

Research shows that pazopanib, a drug used in the combination, is effective in treating advanced kidney cancer by targeting specific proteins involved in cancer growth. Additionally, everolimus, another drug in the combination, has shown benefits in patients with advanced kidney cancer.1381011

Who Is on the Research Team?

AZ

Amado Zurita, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients must give written informed consent prior to initiation of study-related procedures. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
I can swallow pills.
Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
See 7 more

Exclusion Criteria

Your diabetes is not well managed, as shown by high fasting blood sugar levels.
I am not allergic to bevacizumab, pazopanib, or everolimus.
I am not planning to take any experimental drugs but can take bisphosphonates while in this study.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the study drugs (everolimus, bevacizumab, or pazopanib) and may switch to another drug if the disease progresses.

Variable, as long as the doctor thinks it is in the participant's best interest
Weekly visits for the first 4 weeks, then every 4 weeks, with additional tests every 8 weeks

End-of-Treatment

Participants undergo a final assessment after completing the study drug regimen.

Long-Term Follow-Up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months for the first 2 years, every 6 months for the third year, and annually thereafter.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Everolimus
  • Pazopanib
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Group 6Experimental Treatment2 Interventions
Group II: Group 5Experimental Treatment1 Intervention
Group III: Group 4Experimental Treatment2 Interventions
Group IV: Group 3Experimental Treatment2 Interventions
Group V: Group 2Experimental Treatment2 Interventions
Group VI: Group 1Experimental Treatment2 Interventions

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

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Approved in European Union as Avastin for:
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Approved in United States as Avastin for:
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Approved in Japan as Avastin for:
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Approved in Canada as Avastin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Novartis

Industry Sponsor

Trials
1,646
Recruited
2,778,000+
Vasant Narasimhan profile image

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye profile image

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Published Research Related to This Trial

Pazopanib, a multikinase inhibitor, was approved by the US FDA in October 2009 for treating advanced renal cell carcinoma, highlighting its significance in cancer therapy.
The drug targets vascular endothelial growth factor receptors, which play a crucial role in tumor growth and blood vessel formation, making it an effective option for managing this type of kidney cancer.
Pazopanib.Bukowski, RM., Yasothan, U., Kirkpatrick, P.[2021]
In a study of 143 patients with advanced renal cell carcinoma (RCC), over 50% of patients remained on pazopanib therapy for nearly 4 months, demonstrating high persistence and compliance across both treatment-naïve and previously treated groups.
Younger age and higher comorbidity were identified as strong predictors of better persistence and compliance with pazopanib treatment, suggesting that these factors may influence treatment outcomes.
Persistence and compliance with pazopanib in patients with advanced renal cell carcinoma within a U.S. administrative claims database.Hackshaw, MD., Nagar, SP., Parks, DC., et al.[2023]
Pazopanib is an FDA-approved multi-kinase inhibitor effective in treating advanced renal cell carcinoma (RCC), showing significant clinical activity in metastatic cases.
The drug not only targets VEGF receptors but also affects other receptors, which contributes to its side-effect profile, indicating a broader mechanism of action beyond just inhibiting VEGF.
Pazopanib and anti-VEGF therapy.Drabkin, HA.[2021]

Citations

Pazopanib. [2021]
Persistence and compliance with pazopanib in patients with advanced renal cell carcinoma within a U.S. administrative claims database. [2023]
Pazopanib and anti-VEGF therapy. [2021]
A Single-Arm Phase 1b Study of Everolimus and Sunitinib in Patients With Advanced Renal Cell Carcinoma. [2020]
Small molecule targeted therapies for the second-line treatment for metastatic renal cell carcinoma: a systematic review and indirect comparison of safety and efficacy. [2021]
Pazopanib and Statin-Induced Rhabdomyolysis. [2022]
Pazopanib: therapeutic developments. [2021]
Pazopanib: a review of its use in the management of advanced renal cell carcinoma. [2021]
Bevacizumab in combination with IFN-α in metastatic renal cell carcinoma: the AVOREN trial. [2015]
First-line antiangiogenics for metastatic renal cell carcinoma: A systematic review and network meta-analysis. [2022]
Indirect treatment comparison of bevacizumab + interferon-α-2a vs tyrosine kinase inhibitors in first-line metastatic renal cell carcinoma therapy. [2023]
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