A Phase II multicenter trial of Gemcitabine in combination with R1415 (erlotinibhydrochloride) in patients with unresectable pancreatic cancer (locally advanced or metastatic)
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCT2080220332
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion criteria
- Histologically or cytologically confirmed diagnosis of adenocarcinoma or adenosquamous of the pancreas cancer which is unresectable (locally advanced or metastatic).
- ECOG performance status (PS) of 0, 1 or 2.
- Adequate organ functions
Exclusion criteria
- The patient is currently suffering from such pulmonary disorders as sudden pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radioactive pneumonia, or drug-related pneumonia, or he/she has a history of such disease.
- Patients have thoracic radiotherapy.
- Prior treatment with Gemcitabine
- Patients who have had treatment with any investigational drug within 4 weeks prior to entry.
- Patients who have history of serious hypersensitivity reactions with any medicine.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (feasibility), efficacy
- Secondary Outcome Measures
Name Time Method