Pancreatic Cancer
Conditions
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 primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Interventions
DRUGicotinib
Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
DRUGGemcitabine
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients who suffer adverse events | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response assessed by RECIST 1.1 | 3 months |
| Progression-free survival | 4 months |
Countries
China
Contacts
Primary ContactTingbo Liang, MD
Outcome results
None listed