An open-label, multicenter phase II study to compare the efficacy and safety of RAD001 as first-line followed by second-line sunitinib versus sunitinib as first-line followed by second-line RAD001 in the treatment of patients with metastatic renal cell carcinoma

Phase 2

Completed

• Conditions: Cancer of the kidney; metastatic Renal Cell Cancer; 10027656

• Registration Number: NL-OMON36802
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell (or with a component of clear cell) or patients with non-clear cell renal carcinoma.
* Patients with nephrectomy (partial or total) or without nephrectomy.

Exclusion Criteria

* Patients who have received prior systemic treatment for their metastatic RCC.
* Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus) or VEGF inhibitors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is Progression Free Survival (PFS) during or<br /><br>after first-line of both treatments (PFS-1L) according to the RECIST criteria.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Progression Free Survival (PFS) of both arms, for first- and second-line<br /><br>combined (PFS-C) after the second-line treatment<br /><br>* To compare safety profiles of both drugs within the 2 lines strategies<br /><br>* To compare Quality of Life (QoL) according to the FKSI-DRS and EORTC QLQ-C30<br /><br>questionnaires for both arms of treatment<br /><br>* To compare Overall Survival (OS) between the 2 treatment arms<br /><br>* Objective Response Rate (ORR) and duration of response according to RECIST<br /><br>during first-line treatment<br /><br>* Assess plasma/serum changes in biomarkers of angiogenesis pre- and post<br /><br>treatment (VEGFA, VEGFD, sVEGFR2, sVEGFR3, bFGF, PLGF, sVEGFR1, ckit, PDGF)</p><br>