Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma (SNIPP)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma|
- 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. [ Time Frame: Every 12 weeks (2 cycles) ]
- Biochemical response of > 20% drop in; 24-hour urinary metanephrines, catecholamines or serum chromogranin A, sustained for > 12-week period [ Time Frame: Patient specific based on disease progression ]
- Overall survival [ Time Frame: Patient specific based on disease progression ]
- Time to progression [ Time Frame: Patient specific based on disease progression ]
- Overall response rate (PR) + (CR) [ Time Frame: Patient specific based on disease progression ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 18, 2017|
|Primary Completion Date:||January 18, 2017 (Final data collection date for primary outcome measure)|
Experimental: Open label - Sunitinib
Sunitinib, 50mg daily, once daily for 4 weeks followed by a 2-week break
50 mg oral dose daily for 4 weeks, 2 week rest period (repeating 6 week cycles)
Other Name: Sunitinib malate (suntinib; SU11248, SU011248, Sutent®)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843037
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|University Health Network, Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Hôpital Notre-Dame du CHUM|
|Montreal, Quebec, Canada, H2L 4M1|
|University Medical Centre Groningen|
|Principal Investigator:||Jennifer Knox, MD, FRCPC||University Health Network--Princess Margaret Cancer Centre|