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

Betta Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02024633

BD-IC-IV48

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

icotinib plus gemcitabine

Experimental group

Description:

Three dose 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. Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.

Treatment:

Drug: icotinib

Drug: Gemcitabine