Status:
UNKNOWN
Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The ...
Eligibility Criteria
Inclusion
- Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
- ECOG Performance Status of 0 to 1.
- Adequate organ function as defined by study-specified laboratory tests.
- Signed informed consent form.
- Willing and able to comply with study procedures.
Exclusion
- Previous chemotherapy or target therapy.
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- Systemically active steroids.
- Another investigational product within 28 days prior to receiving study drug.
- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
- Infection with HIV, hepatitis B or C at screening.
- Pregnant or lactating.
- Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02278458
Start Date
October 1 2014
End Date
October 1 2016
Last Update
May 22 2015
Active Locations (3)
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1
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
2
Bethune First Hospital of Jilin University
Changchun, Jilin, China, 150081
3
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 150081