A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
This is a Phase II, open label study evaluating pre-operative pazopanib treatment in
previously untreated patients with metastatic clear cell renal cancer. This study follows a
Simon 2 stage design
Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue
after nephrectomy until disease progression is documented. Patients will come off study once
disease progression occurs, where they will then be followed for survival. Subsequent
treatment at the discretion of the treating physician will be documented.
After surgery, all patients will be radiologically evaluated 8 weekly until progression.
Standard radical nephrectomy with lymph node dissection will be performed on those patients
who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable
for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.
Observational Model: Case-Only, Time Perspective: Prospective
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.
Interim analysis after 34 patients have 12 weeks of treatment
United Kingdom: Medicines and Healthcare Products Regulatory Agency