Phase 2 study of 2nd line dose-escalated nab-Paclitaxel for advanced or recurrent gastric cancer (KGSG1301)
- Conditions
- Advanced or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000024333
- Lead Sponsor
- Graduate School of Medical Science, Kumamoto Universit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1)Severe bone marrow suppression 2)Complicated by infection 3)History of hypersensitivity to ABI, PAC or albumin 4)History of serious hypersensitivity 5)Pregnant or nursing woman 6)Significant abnormal electrocardiogram or heart disease to be clinically relevant 7)Pleural effusion or ascites in need of treatment 8)Brain metastases 9)Active double cancer (synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years; carcinoma in situ judged to be cured by local treatment are not considered to be active double cancers) 10)Peripheral neuropathy which were graded 2 or higher 11)Interstitial pneumonia or pulmonary fibrosis 12)HBs antigen or HCV antibody positive 13)Physician concludes that the patient's participation in this trial is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Adversed Event Response Rate Overall Survival Time to Treatment Failure Relative Dose Intensity