Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Renal Cancer With Venous Invasion (NAXIVA)
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|ClinicalTrials.gov Identifier: NCT03494816|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Non-metastatic Renal Cell Carcinoma||Drug: Axitinib Oral Tablet||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NAXIVA- Phase II Neoadjuvant Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Clear Cell Renal Cell Cancer With Venous Invasion|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Axitinib - oral tablet twice daily for 8 weeks prior to surgery. Starting dose 5mg.
Drug: Axitinib Oral Tablet
Axitinib is an oral VEGF-receptor inhibitor. Patients are prescribed a starting dose of 5mg twice daily, escalating to 10mg in absence of dose limiting toxicities and blood pressure.
Doses should be taken approximately 12 hours apart and patients should be instructed to take their doses at approximately the same times each day with or without food as per instruction. On clinic days only, patients will be advised to fast for 6 hours prior to their clinic visit.
Patients should be advised to stop axitinib treatment a minimum of 36 hours and maximum of 7 days prior to week 9 nephrectomy and thrombectomy surgery.
Dose adjustments, including dose increase or dose reduction, are permitted and should be based on clinical judgement and the guidelines provided in the protocol.
- Improvement in Mayo Classification [ Time Frame: Surgery and radiology assessment at week 9 in comparison to pre-axitinib assessment. ]The percentage of evaluable patients with an improvement in the Mayo Classification.
- Surgical approach [ Time Frame: Surgical planning will be conducted at week 1 (prior to axitinib) and compared to the actual outcome at week 9. ]The percentage of patients with a change in surgical management i.e. type of approach and incision, planned control of IVC or renal vein and the involvement of other surgical specialties.
- Venous Tumour Thrombus (VTT) height [ Time Frame: Radiology assessment- The VTT height will be measured prior to axitinib and compared with the VTT height just before surgery (week 9). Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis. ]The percentage of change of VTT height.
- Response rate [ Time Frame: Radiology assessment- The response rate (RECIST) will be assessed at week 9 in comparison to pre-axitinib measurements.Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis. ]The response rate will be measured in accordance with the RECIST (V1.1)
- Morbidity rates [ Time Frame: Morbidity rates will be assessed by radiology assessment using pre-axitinib and week 9 scans. Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis. ]Morbidity will be measured using MRI/CT scanning according to the Clavien-Dindo classification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494816
|Contact: Niki Couper||0131 275 6727||NSS.NAXIVA@nhs.net|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Ellie Couch|
|Principal Investigator: Kate Fife|
|Western General Hospital||Recruiting|
|Edinburgh, United Kingdom, EH4 2XU|
|Contact: Susan Forman|
|Principal Investigator: Steve Leung|
|Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, United Kingdom, G12 0YN|
|Contact: Maria Nicol|
|Principal Investigator: Rob Jones|
|St George's Hospital||Not yet recruiting|
|London, United Kingdom, SW17 0QT|
|Contact: Sam Hollingworth|
|Principal Investigator: Pieter Le Roux|
|London, United Kingdom, SW3 6JJ|
|Contact: Darshana Shah|
|Principal Investigator: David Nicol|
|The Christie||Not yet recruiting|
|Manchester, United Kingdom, M20 4BX|
|Contact: Kate Armitage|
|Principal Investigator: Tom Waddell|
|Principal Investigator:||Grant D Stewart||University of Cambridge|