Sunitinib in the treatment of metastatic Pheochromocytomas/Paragangliomas

SUTNET Trial: Biological and Clinical Phase II study of Sunitinib in patients with unresectable and/or metastatic pheochromocytoma/paraganglioma - SUTNET Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002632-99-IT

Enrollment

Registered

2012-03-07

Start date

2011-10-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with unresectable and/or metastatic pheochromocytomas/paragangliomas MedDRA version: 14.1 Level: LLT Classification code 10001375 Term: Adrenal neoplasm NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: SUTENT*30CPS 50MG Pharmaceutical Form: Capsule INN or Proposed INN: SUNITINIB MALATE CAS Number: 341031-54-7 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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)	—

Countries

Italy

Contacts

Public ContactMilan ENETS Center of Excellence

Fondazione IRCCS Istituto Nazionale Tumori

neuroendocrini@istitutotumori.mi.it00390223902722

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026