Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma (SNIPP)
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|ClinicalTrials.gov Identifier: NCT00843037|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Paraganglioma Pheochromocytoma||Drug: Sunitinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||January 18, 2017|
|Actual Study Completion Date :||January 18, 2017|
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®)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|