JPRN-UMIN000014873CompletedPhase 1
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 1/2 study to assess the the safety of nab-Paclitaxel + trastuzumab therapy and the concept of using trastuzumab beyond progression
Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology0 sites23 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 23
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
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
Investigators
Similar Trials
Completed
Not Applicable
A phase II study of paclitaxel plus trastuzumab in patients with pretreated recurrent or metastatic gastric cancer.advanced gastric cancerJPRN-UMIN000006403Toyama Prefectural Central Hospital30
Completed
Phase 2
Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancerHER2 positive advanced or recurrent gastric cancerJPRN-UMIN000006223Japanese Foundation for Multidisciplinary Treatment of Cancer35
Completed
Phase 1
Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive.HER2-positive gastric cancerJPRN-UMIN000011863Osaka Medical College Hospital100
Recruiting
Phase 1
Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.advanced or recurrent HER2-positive gastric cancerJPRN-UMIN000008623The Cancer Institute Hospital of JFCR36
Recruiting
Phase 2
Phase II study of nab-paclitaxel plus ramucirumab in combination with nivolumab in unresectable advanced or recurrent gastric cancer after progression to first-line therapy including fluoropyrimidine, platinum, and anti-PD-1/PD-L1 antibody.nresectable advanced or recurrent gastric cancerJPRN-jRCT2031220448Shoji Hirokazu45