Phase 2
Completed N=24
Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Renal Cancer With Venous Invasion
Source: ClinicalTrials.gov NCT03494816 ↗Enrolled (actual)
24
Serious AEs
33.3%
Results posted
Jun 2021
Primary outcomePrimary: Number of Patients With a Change in Mayo Classification — 6; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a Change in Mayo Classification |
6; 15 | — |
| SECONDARY % Patients With Change in Surgical Management |
6; 0; 11 | — |
| SECONDARY Change in Venous Tumour Thrombus (VTT) Height |
21.49 | — |
| SECONDARY Number of Patients With RECIST Responses |
0; 3; 13; 2; 0 | — |
| SECONDARY Surgical Complication Rates |
1; 3; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18. 2. Histologically proven clear cell RCC. 3. Immediate resection of the primary tumour considered technically possible. 4. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) 4. cT3b, cT3c, cT3a (main renal vein) 5. N0, N1, or Nx 6. M0, or M1 7. ECOG performance status 0 - 1 8. Urinalysis 160/100 mmHg despite optimised antihypertensive treatment).
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- ALT or AST ≥ 1.5 x ULN; Bilirubin ≥ 1.5 x ULN.
- Serum creatinine ≥ 1.5 x ULN
- Neutrophil count < 1.0 x 109/L; platelet count < 100 x 109/L; Hb ≤ 90g/L.
- Known severe hepatic impairment (Child-Pugh class C)
- Known hypersensitivity to axitinib or any of its excipients. Specifically patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not enter the study.
Data sourced from ClinicalTrials.gov (NCT03494816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.