A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
This study will be a single arm, open-label, phase II trial of sunitinib in patients with
metastatic or locally advanced malignant paraganglioma or phaeochromocytoma. Oral sunitinib
(50 mg) will be administered to all patients daily for the first four weeks of a six week
study cycle, followed by a 2-week rest. Patients will be assessed for response to study
treatment using MRI/CT scans as well as bio-chemical tests, and will receive the study
treatment for up to 12 months or until disease progression.
Primary study outcomes include:
To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6
weeks in patients with advanced or metastatic paraganglioma/ pheochromocytoma.
To assess the toxicity of sunitinib in patients with advanced or metastatic paraganglioma/
pheochromocytoma.
To document effects of sunitinib on markers of biochemical activity of advanced or
metastatic paraganglioma/ pheochromocytoma.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate (CBR) which is defined as either a partial response (PR) complete response (CR) or stable disease (SD) for ≥ 12 weeks measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Every 12 weeks (2 cycles)
No
Jennifer Knox, MD, FRCPC
Principal Investigator
University Health Network, Princess Margaret Hospital
Canada: Health Canada
SNIPP
NCT00843037
February 2009
December 2013
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