At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically documented gastric or gastroesophageal junction adenocarcinoma
- ✓Disease progression or recurrence after one prior chemotherapy regimen for advanced/metastatic disease
- ✓At least 4 weeks since last chemotherapy dose
- ✓Measurable disease by radiographic imaging
- ✕Clinically relevant ascites requiring paracentesis
- ✕Severe weight loss
- ✕Grade 3 hemorrhage within 4 weeks of study start
- ✕History of second malignancy within 3 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Progressing Or Recurring After One Prior Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Sunitinib for Stomach Neoplasms. Completed, enrolled 78 participants across 18 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed