Advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Conditions
Interventions
GBS-01 is orally administered at the dose of 6g q.d.
Sponsors
National Cancer Center Hospital East
Kracie Pharma, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven invasive ductal carcinomas of pancreas (papillary adenocarcinoma, tubular adenocarcinoma -well differentiated type, -moderately differentiated type ,or poorly differentiated adenocarcinoma, adenosquamous carcinoma) 2)Refractory to gemcitabine and fluoropyrimidine chemotherapy by the following reason. i)Radiologically or clinically confirmed progression disease ii)Recurrence during or within 12 weeks after the last administration of the adjuvant/ neoadjuvant chemotherapy 3)Adequate oral intake 4)Having a measurable lesion according to RESICT ver1.1 5)Aged 20 or over 6)PS (ECOG) of 0 to 1 7)The period from the end of previous treatment to the enrollment must be satisfied following criteria. - GEM, S-1, GEM+S-1, GEM+erlotinib, immunotherapy, or palliative radiotherapy: >=14 days - other chemotherapy or radiotherapy for pancreas : >=28 days 8)Adequate organ function 9)Written informed consent
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Response rate (RR) Progression free survival (PFS) Overall survival (OS) PK parameter effect to cancer stem-like cell | — |
Countries
Japan
Contacts
Public ContactAkihiro Sato
National Cancer Center Exploratory Oncology Research & Clinical Trial Center Clinical Trial Section
Outcome results
None listed