An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2
step design) after which Step 2 was opened and the total enrollment target for the study
(n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study
did not open due to the final overall insufficiency of efficacy observed in 78 patients.
Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a
starting dose of 50 mg with provision for dose reduction based on tolerability. All patients
received repeated cycles of sunitinib until disease progression, occurrence of unacceptable
toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients
were followed up in order to collect information on further antineoplastic therapy and
survival.