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

NCT ID: NCT02278458

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

icotinib plus gemcitabine

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.

Group Type: EXPERIMENTAL

icotinib

Intervention Type: DRUG

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.

Gemcitabine

Intervention Type: DRUG

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

Interventions

icotinib

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.

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Other Intervention Names

Commana; Gemzar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanqiao Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of Harbin Medical University

Locations

Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Bethune First Hospital of Jilin University

Changchun, Jilin, China

First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

BD-IC-IV70

Identifier Type: -

Identifier Source: org_study_id