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Study to Compare Tivozanib Hydrochloride to

Sorafenib in Subjects With Refractory Advanced RCC

 
 
 Phase 3 trial recruiting approx. 322 patients worldwide
 Last updated:November 29, 2017
 STATUS: Ongoing, not recruiting (not accepting new patients) (per ClinicalTrials.gov/NCT02627963)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:

  • histologic confirmation of RCC with clear-cell component
  • advanced and/or metastatic disease
  • patients may have had 2 or 3 prior systemic therapies (one of which must include a VEGFR TKI other than sorafenib or tivozanib); previous therapies may include a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor]
  • overall health status has to be good (ECOG performance status of 0 or 1)

WHAT

is the key question that this trial is attempting to answer?

This phase 3 study seeks to clarify whether a new therapy (tivozanib) is superior to one of the standard therapies (sorafenib) when taken as a third-line or fourth-line treatment option for patients with metastatic kidney cancer mRCC.

WHY

patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy that may be effective for kidney cancer. This trial will further support the research in kidney cancer and potentially help other patients with kidney cancer. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN

will the trial be open?

This study is open (recruiting patients) – 322 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available in 191 cancer centres worldwide.
For a complete list of trial locations, please click here:
 Trial locations
 

STUDY

DESIGN

What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) into two groups. Please note that patients in all groups will receive an active medication. No patient will receive a placebo.

Patients in group 1 will be assigned tivozanib. Patients in group 2 will be treated with sorafenib (NexavarTM).

  • tivozanib (AV-951) is an oral VEGF receptor tyrosine kinase inhibitor that has not yet been approved for the treatment of metastatic renal cell carcinoma
  • sorafenib (NexavarTM) is an oral, small-molecule, tyrosine kinase inhibitor, already approved for the treatment of metastatic renal cell carcinoma
tivozantinib vs. sorafenib
 
1) Tivozanib is given by mouth once a day for 3 weeks, then 1 week off.

2) Sorafenib is given by mouth twice daily.

HOW

do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving kidney cancer patients. If there are no such organisations in your country, please email us for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

CONNECT

with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.

SHARE

your experience 

If you would like to share your experience on this trial, send us an e-mail to:This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS

of the study

No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
 
Back to clinical trials overview: How can I find a clinical trial for kidney cancer?