Phase I clinical study of ABI-007 in combination with gemcitabine
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-jRCT2080223124
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 40
Has personally given written informed consent to participate in this clinical study
- Pancreatic adenocarcinoma histologically confirmed to be invasive ductal carcinoma
- Macroscopic examination shows that the primary pancreatic lesion has been completely resected
- Has undergone surgery for primary pancreatic tumor within 12 weeks before the start of study treatment
- Pancreatic cancer staging: T1-3, N0-1 and M0 by TNM classification (the seventh edition, proposed by UICC in 2009)
- History of treatment other than surgery (chemotherapy, radiotherapy, etc.) for the primary pancreatic tumor
- Grade 2 or higher peripheral sensory or motor neuropathy
- As judged by the investigator (subinvestigator), ineligible for entry into the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>tolerability
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>other<br>safety, treatment exposure and efficacy