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Trial of X4P-001 in Patients With

Advanced Renal Cell Carcinoma

 
 
 
 Last updated: January 29, 2017
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT02667886)

WHO

is the trial for?

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

  • histologically confirmed diagnosis of predominant clear cell renal cell carcinoma (ccRCC)
  • advanced disease with at least one lesion (metastasis) outside of the kidney
  • at least one prior treatment
  • overall health status has to be good (ECOG less than 2)

WHAT

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

This phase-I/II study aims to evaluate the safety and tolerability of a new immune therapy for patients with kidney cancer as well as the potential effect it may have on the body and the tumour.

This study investigates a new therapy (the CXCR4 antagonist called X4P-001) given alone or in combination with axitinib in patients with advanced renal cell carcinoma (RCC). Axitinib (InlytaTM) is a tyrosine kinase inhibitor, already approved for the treatment of advanced kidney cancer.

WHY

patients might want to participate?

This clinical trial offers patients an opportunity to access a new combination 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?

The study is open (recruiting) – 83 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available in 7 cancer centres in the USA.
For contact details, please click here: ClinicalTrials.gov/ NCT02667886
 

STUDY

DESIGN

What does the study look like?

The trial will be conducted in three parts:

Part A – Phase I trial:
The Phase 1 portion of the study will test the safety and tolerability of X4P-001 in combination with axitinib (InlytaTM). Both agents will be administered orally (given as tablets) twice daily using a dose escalation scheme. This means that the dose will slowly get higher until the disease progresses or unacceptable side effects occur.

  • X4P-001 is an oral, small molecule inhibitor of CXCR4. Recent studies demonstrate that CXCR4 enables cancer cells and surrounding stromal cells to block normal immune function and promote angiogenesis so that the cancer can grow. Therefore, blocking CXCR4 may prevent tumour growth.
  • axitinib (Inlyta™) is an oral, small-molecule, tyrosine kinase inhibitor, already approved for the treatment of metastatic renal cell carcinoma.
Part B – Phase II:
When the best dose is found, all patients will be randomly divided (by a computer) into two groups:

Group 1 will receive X4P-001 at the maximum tolerated dose (MTD) detected in Part A, in combination with axitinib

Group 2 will receive X4P-001 with half of the maximum tolerated dosage detected in Part A, in combination with axitinib.

Part C – Phase II:
Patients in this group will receive X4P-001 alone (monotherapy). Note for Part C, patients must have had at least one prior VEGF therapy.

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 are participating on this trial and want to share your experiences, please feel free to 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 (with your name omitted) 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 an IO clinical trial for my cancer?