Status:
COMPLETED
An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Lead Sponsor:
Pfizer
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00226811
Start Date
January 1 2006
End Date
May 1 2008
Last Update
March 30 2015
Active Locations (18)
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1
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
2
Pfizer Investigational Site
Beijing, China, 100036
3
Pfizer Investigational Site
Beijing, China
4
Pfizer Investigational Site
Guangzhou, China, 510515