Study on Pazopanib With or Without Abexinostat for Advanced or Metastatic Kidney Cancer (RENAVIV)
Sponsor: Xynomic Pharmaceuticals, Inc.
ClinicalTrials ID:NCT03592472
This clinical trial is testing whether adding the drug Abexinostat to Pazopanib can improve treatment for patients with advanced or metastatic kidney cancer. Participants will be randomly assigned to receive either the combination of both drugs or Pazopanib with a placebo.
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Program Overview
The study aims to find out if combining the drug Abexinostat with Pazopanib is more effective than using Pazopanib alone in treating patients with advanced kidney cancer that cannot be surgically removed or has spread to other parts of the body. Participants will be randomly assigned to one of the two treatment groups and will continue treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop.
Description
In this study, patients with advanced kidney cancer will be randomly assigned to receive either a combination of Pazopanib and Abexinostat or Pazopanib with a placebo. If the cancer progresses, patients in the placebo group can switch to the combination treatment. Before starting, patients will undergo screening to ensure they meet the study criteria. Treatment cycles last 28 days, and patients can continue receiving the study drugs until their cancer progresses, they experience severe side effects, or they decide to stop. There is no set limit on how long patients can stay on the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of kidney cancer with a clear cell component.
- Have advanced cancer that cannot be surgically removed or has spread.
- Have measurable cancer as determined by the study doctor.
- Must not have received prior treatment with VEGF tyrosine kinase inhibitors.
- May have had one prior treatment with cytokine or immune checkpoint inhibitors if the cancer has progressed.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ and blood function.
- Must be at least two weeks from the last cancer treatment or radiation before starting the study.
Exclusion Criteria
- Have significant side effects from previous cancer treatments, except for hair loss or certain lab abnormalities that are manageable.
- Have untreated cancer that has spread to the brain or spinal cord.
- Have another cancer that required treatment in the past three years, except for certain skin cancers or non-invasive cancers.
- Have poorly controlled high blood pressure.
- Have had a new blood clot in the lungs or deep veins within three months before starting the study.
- Have a heart rhythm problem with a QTcF interval over 480 milliseconds.
- Have severe heart failure (Class III or IV).
- Have used certain prohibited medications shortly before starting the study.
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