Phase1/2 study of nab-Paclitaxel + trastuzumab therapy in 2nd line treatment for HER2-positive advanced or recurrent gastric cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.
Phase 1
- Conditions
- HER2-positive gastric cancer
- Registration Number
- JPRN-UMIN000014873
- Lead Sponsor
- Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
Not provided
Exclusion Criteria
1. Discontinuation of tratuzumab due to adverse event 2. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma 3. Evidence of any other serious disease 4. Active local or systemic infection under treatment 5. History of serious allergic reaction 6. Pulmonary fibrosis or interstitial pneumonitis detected by chest X-ray 7. Symptomatic brain metastases or carcinomatous meningitis 8. Massive pericardial effusion, pleural effusion or ascites 9. Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0 10. Pregnant or lactating female 11. Judged inappropriate by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1: Maximum tolerated dose and recommended dose Phase 2: Response rate (RR)
- Secondary Outcome Measures
Name Time Method Phase 1: Response rate(RR), incidence and degree of adverse events Phase 2: Progression free survival (PFS), Overall survival (OS), Incidence of adverse events