Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
This trial is active, not recruiting.
|Sponsor||Betta Pharmaceuticals Co.,Ltd.|
|Start date||October 2014|
|End date||January 2016|
|Trial size||24 participants|
|Trial identifier||NCT02278458, BD-IC-IV70|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Harbin, China||Cancer Hospital of Harbin Medical University||no longer recruiting|
|Changchun, China||Bethune First Hospital of Jilin University||no longer recruiting|
|Shenyang, China||First Affiliated Hospital of China Medical University||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
The number of patients who suffer adverse events
time frame: 24 months
Tumor response assessed by RECIST 1.1
time frame: 3 months
time frame: 4 months
Male or female participants from 18 years up to 70 years old.
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.
|Official title||Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer|
|Principal investigator||Yanqiao Zhang, MD|
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