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Phase 2a trial of GBS-01 for advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy.

Phase 2
Conditions
Advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Registration Number
JPRN-UMIN000010111
Lead Sponsor
ational Cancer Center Hospital East
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
47
Inclusion Criteria

Not provided

Exclusion Criteria

1)Prior treatment of medicines or supplements extracted from Arctium lappa linne for pancreatic cancer 2)Lactose intolerance 3)Moderate or massive pleural effusion or ascites 4)Symptomatic brain metastasis or a history of brain metastasis 5)Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 6)Psychiatric disease 7)Active infection that requires systemic therapy 8)Other serious complications 9)Pregnant females or nursing mothers who can't stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. 10)Patient is judged as inappropriate for study participation by the investigator for any reason.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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