A PHASE I / II TRIAL OF WEEKLY ABI-007 PLUS GEMCITABINE IN PATIENTS WITH METASTIC PANCREATIC CANCER(10041120)
Phase 1
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCT2080221942
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Patients must be diagnosed as invasive ductal carcinoma.
-Patient must have received no previous therapy.
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
-Written informed consent.
Exclusion Criteria
- Patient has pre-existing peripheral neuropathy or symptoms of peripheral sensory.
- Patient has uncontrollable pain symptoms.
- Patient has uncontrolled or severe diabetes.
- Patient has complication or history of serious lung disease, serious heart disease, serious cerebrovascular disorder, or other serious diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I:tolerability, Phase II: Overall Response Rate<br>Phase I: The primary objective of this study is to evaluate tolerability of the combination of ABI-007 and gemcitabine in patients with metastatic adenocarcinoma of the pancreas.<br>Phase II: The primary objective of this study is to evaluate the objective tumor response in patients with metastatic adenocarcinoma of the pancreas according to RECIST guidelines (Overall Response Rate)
- Secondary Outcome Measures
Name Time Method Safety, Efficacy<br>The secondary objectives are to evaluate adverse drug reactions and efficacy in patients with metastatic adenocarcinoma of the pancreas.