NCT01408004

Rotating Pazopanib and Everolimus to Avoid Resistance

A Randomized Phase II Study to Explore the Efficacy and Feasibility of Upfront Bi-monthly Rotations Between Everolimus and Pazopanib in Patients With Advanced or Metastatic Clear Cell Renal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Netherlands Working Group on Immunotherapy of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study will be examined whether alternating treatment between two classes of drugs (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal cancer.

Detailed description

Current practice is to treat with VEGFR-TKI or mTOR inhibitors until progression and then continue with the next active agent. From a biological perspective, TKI's will most likely activate compensatory pathways which, may ultimately lead to the development of resistance. Recent studies suggest that resistance to treatment with TKI may be reversible after stopping treatment. There is therefore a rationale to alternate treatment to prevent or delay the occurrence of resistance. Our hypothesis is that alternating active agents in clear cell renal carcinoma (ccRCC) may reduce side effects, improve tolerability and compliance of treatment and prolong progression free survival and overall survival compared to the standard of care.

Conditions

• Clear Cell Renal Carcinoma

Interventions

Type	Name	Description
DRUG	Pazopanib	Tablet 800mg qd til progression
DRUG	Everolimus	tablet 10 mg qd til progression
DRUG	Pazopanib	tablet 800mg qd, alternating schedule: 8 weeks Pazopanib, 8 weeks Everolimus
DRUG	Everolimus	tablet 10mg qd, alternating schedule: 8 weeks Pazopanib, 8 weeks Everolimus
DRUG	Everolimus	Everolimus 10mg qd monotherapy until second progression (PD per RECIST 1.1)when first progression after 8 weeks of Pazopanib in alternating regimen
DRUG	Pazopanib	Pazopanib 800mg qd monotherapy until second progression (PD per RECIST 1.1) when first progression after 8 weeks of Everolimus in alternating regimen

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-08-02
• Last updated: 2014-07-16

Locations

17 sites across 1 country: Netherlands