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Tyrosine Kinase Inhibitor

Pazopanib for Kidney Cancer

Phase 3

Recruiting

Research Sponsored by Xynomic Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients have locally advanced and unresectable or metastatic disease.

Patients aged ≥ 18 years at time of study entry.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization date to date of first documentation of progression or death (up to approximately 4 years).

Awards & highlights

Study Summary

This trial is testing a new combination treatment for kidney cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Pazopanib may cause liver issues, high blood pressure, fatigue, diarrhea, and changes in hair color. Abexinostat could potentially add side effects like nausea and low blood cell counts which can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed by surgery and has spread.

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I am 18 years old or older.

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My kidney cancer has been confirmed by a lab test.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization date to date of first documentation of progression or death (up to approximately 4 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization date to date of first documentation of progression or death (up to approximately 4 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date to date of first documentation of progression or death (up to approximately 4 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5

DOR by RECIST version 1.1 in cross-over patient population

Duration of response (DOR)

+6 more

Side effects data

From 2019 Phase 2 trial • 30 Patients • NCT01466972

53%

Fatigue

50%

Nausea

37%

Diarrhea

33%

Back pain

30%

Hypertension

30%

Anorexia

23%

Abdominal pain

20%

Bone pain

17%

Dyspnea

17%

Vomiting

17%

Headache

17%

Aspartate aminotransferase increased

13%

Arthralgia

13%

Constipation

13%

Palmar-plantar erythrodysesthesia syndrome

13%

Alanine aminotransferase increased

13%

Investigations - Other

10%

Anemia

10%

Blurred vision

10%

Chills

10%

Pain in extremity

10%

Hot flashes

10%

Dysgeusia

10%

Rash maculo-papular

10%

Alkaline phosphatase increased

Urinary incontinence

Platelet count decreased

Alopecia

Skin and subcutaneous tissue disorders - Other

White blood cell decreased

Neutrophil count decreased

Urinary frequency

Cough

Urinary tract pain

Dry Mouth

Gastroesophageal reflux disease

Fever

Dyspepsia

Non-cardiac chest pain

Hypothyroidism

Hyperglycemia

Hyponatremia

Peripheral motor neuropathy

Blood bilirubin increased

Pleural effusion

Hypotension

Back Pain

Thromboembolic event

Heart Failure

Small intestinal obstruction

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Pazopanib in Combination With a NSAI

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abexinostat

Not yet FDA approved

Pazopanib

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xynomic Pharmaceuticals, Inc.Lead Sponsor

10 Previous Clinical Trials

796 Total Patients Enrolled

Pamela Munster, M.D.Study ChairUniversity of California, San Francisco

1 Previous Clinical Trials

6 Total Patients Enrolled

Rahul Aggarwal, M.D.Study ChairUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a research project like this one been conducted before?

"Pazopanib has undergone 31 clinical trials in 23 countries and 616 cities since 2011. The first study was sponsored by Novartis and completed Phase 2 approval with 180 patients. To date, a total of 18423 studies have been completed."

Answered by AI

Pazopanib has been deemed a safe medication, correct?

"Pazopanib has received a safety score of 3 from our team at Power. This is because Pazopanib has progressed to Phase 3 trials, meaning that there is efficacy data as well as multiple rounds of safety data supporting its use."

Answered by AI

Are there any available slots for individuals who wish to enroll in this research?

"The online clinical trials database shows that this study is still recruiting patients. This particular trial was first posted on July 17th, 2018 and the most recent update was on August 18th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

2018. "A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03592472.