413 Participants Needed

Pazopanib + Abexinostat for Kidney Cancer

Recruiting at 1 trial location
SP
RA
Overseen ByRahul Aggarwal, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Xynomic Pharmaceuticals, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any prohibited medications at least 7 days or 5 half-lives before starting the study drug. However, the protocol does not specify which medications are prohibited, so it's best to discuss your current medications with the study team.

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

Pazopanib has been shown to be effective in treating advanced kidney cancer by inhibiting certain proteins that help cancer cells grow. In a clinical trial, patients taking pazopanib had a longer period without cancer progression compared to those taking a placebo.12345

Is the combination of Pazopanib and Abexinostat safe for humans?

Pazopanib, used for advanced kidney cancer, is generally well tolerated but can cause side effects like abnormal liver function tests. It is important to monitor these effects during treatment.12367

What makes the drug Pazopanib unique for kidney cancer treatment?

Pazopanib is unique because it is an oral drug that targets multiple pathways involved in cancer growth, specifically inhibiting the vascular endothelial growth factor receptors (VEGFR), which play a key role in the formation of blood vessels that supply tumors. This makes it different from other treatments that may not target these specific pathways or are not taken orally.12368

What is the purpose of this trial?

This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).

Research Team

PM

Pamela Munster, M.D.

Principal Investigator

University of California, San Francisco

RA

Rahul Aggarwal, M.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults with advanced kidney cancer that hasn't spread to the brain can join this study. They should have clear cell renal carcinoma, measurable disease, and no prior treatments with certain cancer drugs. Good blood counts and organ function are needed, and they must be at least two weeks out from previous treatments.

Inclusion Criteria

It has been at least 2 weeks since my last cancer treatment.
Your disease can be measured by the doctor using specific guidelines.
I haven't been treated with VEGF inhibitors but may have had one round of immunotherapy.
See 5 more

Exclusion Criteria

I have lasting side effects from cancer treatment, but not hair loss.
I have had another cancer within the last 3 years, but it was either skin cancer, a localized cancer that hasn't spread, or a non-invasive bladder cancer.
I haven't taken any forbidden medications recently.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive pazopanib plus abexinostat or pazopanib plus placebo in 28-day cycles until disease progression or unacceptable toxicity

Up to approximately 4 years
Visits on Day 1 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years
Every 3 months follow-up until death or study closure

Crossover

Participants in the placebo arm may cross over to receive pazopanib plus abexinostat upon disease progression

Until disease progression or unacceptable toxicity

Treatment Details

Interventions

  • Abexinostat
  • Pazopanib
Trial Overview The RENAVIV trial is testing whether adding Abexinostat to Pazopanib improves outcomes in kidney cancer compared to using Pazopanib alone. Participants will be randomly assigned to receive either the combination or just Pazopanib with a placebo without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pazopanib plus abexinostatExperimental Treatment2 Interventions
Randomized patients will receive a combination of pazopanib plus abexinostat. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat p.o twice daily (BID) on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of abexinostat at the same time each day.
Group II: Pazopanib plus placeboPlacebo Group2 Interventions
Randomized patients will receive a combination of pazopanib plus abexinostat matching placebo. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat matching placebo p.o BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of placebo at the same time each day.

Pazopanib is already approved in United States, European Union, China for the following indications:

🇺🇸
Approved in United States as Votrient for:
  • Advanced renal cell carcinoma (kidney cancer)
  • Soft tissue sarcoma
🇪🇺
Approved in European Union as Votrient for:
  • Advanced renal cell carcinoma (kidney cancer)
  • Soft tissue sarcoma
🇨🇳
Approved in China as pazopanib for:
  • Metastatic renal cell carcinoma (mRCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xynomic Pharmaceuticals, Inc.

Lead Sponsor

Trials
11
Recruited
1,200+

Findings from Research

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]
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]
Pazopanib is a potent pan-VEGF inhibitor that has shown clinical efficacy in treating metastatic renal cell carcinoma, leading to its recent FDA approval.
In a Phase III clinical trial, pazopanib demonstrated similar effectiveness to other approved treatments but exhibited different toxicity profiles, which may help differentiate it from other VEGFR inhibitors.
Pazopanib: therapeutic developments.Limvorasak, S., Posadas, EM.[2021]

References

Pazopanib and anti-VEGF therapy. [2021]
Pazopanib. [2021]
Pazopanib: therapeutic developments. [2021]
Persistence and compliance with pazopanib in patients with advanced renal cell carcinoma within a U.S. administrative claims database. [2023]
Pazopanib. Kidney cancer: many risks, but is there a benefit for patients? [2021]
Bioavailability, metabolism and disposition of oral pazopanib in patients with advanced cancer. [2021]
Pazopanib: a review of its use in the management of advanced renal cell carcinoma. [2021]
Pazopanib, a new therapy for metastatic soft tissue sarcoma. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security