A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Pfizer

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: sunitinib malate; Drug: sunitinib malate dose escalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396148

2011-002008-33 (EudraCT Number)

A6181196

Details and patient eligibility

About

Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.

Enrollment: 6 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of GIST.
• Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
• Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease.

Exclusion criteria

• Current treatment with another investigational agent.
• Prior sunitinib treatment.
• Prior therapy with known risk for cardiovascular complications.

Trial design

6 participants in 2 patient groups

Children with GIST

Experimental group

Description:

children ages 6yrs-\<18yrs

Treatment:

Drug: sunitinib malate dose escalation

Young adults with GIST

Experimental group

Description:

young adults ages 18yrs-\<21 yrs

Treatment:

Drug: sunitinib malate