Treatment With SU11248 in Patients With Neuroendocrine Tumors

Pfizer

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056693

RTKC-0511-015

Details and patient eligibility

About

To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
• Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
• ECOG performance status 0 or 1

Exclusion criteria

• Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
• Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

107 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Sunitinib