Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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 primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.