Sunitinib in the treatment of metastatic Pheochromocytomas/Paragangliomas
- Conditions
- Patients with unresectable and/or metastatic pheochromocytomas/paragangliomasMedDRA version: 14.1Level: LLTClassification code 10001375Term: Adrenal neoplasm NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002632-99-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LA CURA TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Age >=18 years Patients with histological diagnosis of malignant pheochromocytoma or paraganglioma and either evidence of metastases or unresectability Measurable lesions according to RECIST criteria ECOG Performance Status 0-2 Life expectancy of at least 12 weeks Adequate cardiac, hepatic, renal, and bone marrow function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
Major surgical procedure within 28 days prior to study treatment start Evidence of current central nervous system (CNS) metastases or spinal cord compression. Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, meningiomas) Clinically significant cardiovascular disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Sunitinib in patients with metastatic pheochromocytomas/paragangliomas in terms of PFS;Secondary Objective: The overall survival (OS) and objective response (ORR) according to RECIST Criteria. To characterize the safety profile of Sunitinib To evaluate HIF-1 expression (optional study) To evaluate the effects of treatment with Sunitinib on circulating plasma levels of VEGF and their correlation with the response to treatment (optional study);Primary end point(s): The primary efficacy end point is one year progression free survival (PFS). To test a gain in PFS from 30%, representing insufficient treatment activity, to 50%, which is the therapeutic target, the Simon’s optimal two stage design requires the assessment of 22 patients at stage I and 46 patients at stage II. This according to a 10% Type I and Type II error probability levels.;Timepoint(s) of evaluation of this end point: The primary efficacy end point is one year progression free survival (PFS).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The overall survival (OS) and objective response rate (ORR) will be considered as secondary end points.;Timepoint(s) of evaluation of this end point: At the end of the study (48 months)