An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Stomach Neoplasms
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria: Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion Evidence of measurable disease by radiographic technique Adequate organ function. Exclusion Criteria: Clinically relevant ascites (i.e. requiring paracentesis) Severe weight loss NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment Diagnosis of second malignancy within last 3 years History of or known brain metastases, spinal cord compression, or carcinomatous meningitis Known HIV Serious acute or chronic illness Current treatment on another clinical trial Pregnant or breastfeeding
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Experimental
A
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