Phase 1/2 study of GBS-01 in patients with gemcitabine-refractory advanced pancreatic cancer.
Not Applicable
- Conditions
- Patients with gemcitabine-refractory advanced pancreatic cancer.
- Registration Number
- JPRN-UMIN000005787
- 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
- 23
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1:Frequency of dose limiting toxicities Phase 2:Response rate
- Secondary Outcome Measures
Name Time Method PK parameter Adverse events Progression free survival Overall survival