RENAVIV
Research type
Research Study
Full title
A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
IRAS ID
248528
Contact name
Mira-Bianca Stanescu
Contact email
Sponsor organisation
Xynomic Pharmacuthicals
Eudract number
2018-001495-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 6 months, 18 days
Research summary
Clear cell renal cell carcinoma (CCRCC) is a kidney cancer that originates in the very small tubes in the kidney that transport urine. It is the most common type of kidney cancer in adults. This study will include participants with locally advanced or metastatic clear cell renal cell carcinoma. Locally advanced means that the cancer has spread from where it started to nearby tissue or lymph nodes. Metastatic means that the cancer cells have moved from where they first formed to another part of the body.
Current therapy of CCRCC involves immunotherapy (the prevention or treatment of disease with substances that stimulate the immune response) with checkpoint inhibitors (type of drugs that block certain proteins made by some types of immune system cells, such as T cells, and some cancer cells) and molecularly targeted therapy is the primary systemic modalities for the management of patients whose disease is not controlled by definitive locoregional therapy (refers to various minimally invasive therapeutic procedures).
Sponsor Xynomic Pharmaceuticals Inc. is developing a new anticancer agent Abexinostat. Abexinostat, is a novel histone deacetylase (HDAC) inhibitor. Histone deacetylase inhibitors have been reported to cause growth arrest, differentiation, and apoptosis (a process of programmed cell death) in tumour cells and to inhibit tumour growth in vivo. Abexinostat is being developed for the treatment of solid tumours and hematologic malignancies.
This is a study to assess whether the investigational new drug, abexinostat, will improve the effects of pazopanib (the approved drug) in treating clear cell renal cell carcinoma. Participants with clear cell renal cell carcinoma who agree to be in this study will take pazopanib and either tablets containing abexinostat or placebo, in order to have comparative results at the end of the study.
There will be approximately 413 participants taking part in this study at about 70 study centres globally.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0004
Date of REC Opinion
6 Feb 2019
REC opinion
Further Information Favourable Opinion