Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

Pfizer

Status: Completed

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Sunitinib malate; Drug: sunitinib malate

Study type: Observational

Funder types: Industry

Identifiers

NCT00444795

A6181146

Details and patient eligibility

About

To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Full description

All the patients prescribed according to approved indications at contracted institutions

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, or advanced renal cell carcinoma (aRCC) will be included in the study, or patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma.

Exclusion criteria

• Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information will be excluded.
• Patients with hypersensitivity to sunitinib malate or to any other component of Sutent

Trial design

520 participants in 3 patient groups

1

Description:

patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate

Treatment:

Drug: Sunitinib malate

Drug: Sunitinib malate

2

Description:

patients diagnosed as advanced RCC

Treatment:

Drug: Sunitinib malate

Drug: Sunitinib malate

3

Description:

patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma

Treatment:

Drug: sunitinib malate