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

Completed · Phase 2

Conditions studied: Gastrointestinal Stromal Tumors

In brief

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.

Key facts

Study ID

NCT01396148

Run by

Pfizer

People needed

6

Starts

2012-06-01

Expected to finish

2017-08-01

Last updated by the study team

2019-03-27

Who can join

Age: 6 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Fakultni nemocnice Brno — Brno, Czechia
• FN Brno — Brno, Czechia
• Masarykuv onkologicky ustav — Brno, Czechia
• CHU de La Timone, Hopital enfants — Marseille, France
• Hopital d'Enfants de la Timone — Marseille, France
• Hopital de la Timone — Marseille, France

Full record on ClinicalTrials.gov

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