Patients with gemcitabine-refractory advanced pancreatic cancer.
Conditions
Interventions
GBS-01 is administered orally once daily until disease progression or unacceptable toxicity.
Sponsors
National Cancer Center Hospital East
University of Toyama Kracie Pharma, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven invasive ductal carcinomas (papillary adenocarcinoma, tubular adenocarcinoma -well differentiated type, -moderately differentiated type , poorly differentiated adenocarcinoma, adenosquamous carcinoma) 2) Refractory to gemcitabine-based chemotherapy by the following reason. i)Radiologically or clinically confirmed progression disease ii) Recurrence during or within 12 weeks after administration of the adjuvant chemotherapy iii)Unacceptable toxicities 3) Adequate oral intake 4) Having a measurable lesion according to RECIST ver1.1 5) Aged 20 or over 6) PS (ECOG) of 0 to 2 7) More than 14 days interval from prior chemotherapy. 8) Adequate organ function 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Moderate or massivepleural effusion or ascites 2) Symptomatic brain metastasis or a history of brain metastasis 3) Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 4) Severe mental disorder 5) Active infection 6) Serious complications (intestinal paralysis, intestinal obstruction, poorly controlled diabetes, heart failure, renal failure, hepatic failure , active gastrointestinal ulcer) 7) Women during pregnancy or breast-feeding 8) Inadequate physical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1:Frequency of dose limiting toxicities Phase 2:Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter Adverse events Progression free survival Overall survival | — |
Countries
Japan
Outcome results
None listed