Clinical Trials Logo
NCT number NCT03494816
Study type Interventional
Source Scottish Clinical Trials Research Unit
Contact Niki Couper
Phone 0131 275 6727
Email NSS.NAXIVA@nhs.net
Status Recruiting
Phase Phase 2
Start date December 15, 2017
Completion date June 1, 2020

Clinical Trial Summary

NAXIVA is a study of axitinib in patients with metastatic and non-metastatic renal cell carcinoma with venous invasion. Patients will be given axitinib (twice daily) for 8 weeks (at an escalated dose) and the response of the venous invasion will be assessed.

Blood, urine and tumour tissue samples will be taken prior to and during therapy to evaluate biomarkers of treatment response.

The primary objective is to assess the response of the thrombus to axitinib. Its thought that axitinib will reduce the extent of the thrombus in the inferior vena cava will reduce the extent of surgical intervention.


Clinical Trial Description

NAXIVA is a single arm, single agent, open label, phase II feasibility study of axitinib in patients with both metastatic and non-metastatic renal cell carcinoma of clear cell histology. 20 patients will be recruited from multiple centres within the United Kingdom.

Patients who have signed informed consent and who have met all eligibility criteria will be registered into the trial.

The starting dose of axitinib will be 5mg BID and escalated to 7mg BID and then 10mg BID. A dose modification assessment will take place every 2 weeks in clinic during the 8 week pre-surgical treatment period and will be dependent on tolerability of treatment. Patients will follow an aggressive axitinib dose escalation process within the 8 week period to a maximum of 10mg BID. Patients should stop axitinib a minimum of 36 hours and a maximum of 7 days prior to surgery in week 9.

Blood, urine and tissue samples will be taken prior to and during therapy to evaluate biomarkers of treatment response. Nephrectomy and IVC tumour thrombectomy will be planned for all patients on the trial.

Response to axitinib in VTT, primary tumour and any RECIST measureable lesion will be correlated with changes in molecular markers.

Patients will be followed up in clinic at 6 & 12 weeks post surgery.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03173560 - Trial to Assess Safety and Efficacy of Lenvatinib in Combination With Everolimus in Participants With Renal Cell Carcinoma Phase 2
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT02853344 - Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) Phase 2
Recruiting NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Recruiting NCT03050047 - A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT03052504 - Prospective Versus Retrospective Complications in Radical Cystectomy and Nephrectomy N/A
Not yet recruiting NCT02787915 - DC1s-CTL Cellular Therapy for Renal Cell Carcinoma Phase 1/Phase 2
Active, not recruiting NCT02526017 - Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT02307474 - A Pilot Study of SBRT With Adjuvant Pazopanib for Renal Cell Cancer N/A
Active, not recruiting NCT02133742 - A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer Phase 1
Active, not recruiting NCT01482949 - A Rollover Protocol for Subjects Previously Treated With AGS-003 Phase 2
Active, not recruiting NCT01420601 - Temsirolimus (Torisel) Special Investigation (Regulatory Post Marketing Commitment Plan) N/A
Completed NCT01283048 - Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma Phase 1
Terminated NCT00975806 - Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT00970970 - Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease N/A
Withdrawn NCT00556205 - Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma Phase 2
Terminated NCT01063998 - A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma N/A
Completed NCT00980213 - Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland N/A
Active, not recruiting NCT00749320 - Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC) N/A
Completed NCT01404104 - Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma N/A