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

Phase 1UnknownNCT02024633

Betta Pharmaceuticals Co., Ltd.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

icotinibDRUG

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.

GemcitabineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Second Affiliated Hospital of Zhejiang Univercity School of Medcine

Hangzhou, China

RECRUITING

Outcomes

Primary Outcomes

The number of patients who suffer adverse events

Time frame: 24 months

Secondary Outcomes

Tumor response assessed by RECIST 1.1

Time frame: 3 months

Progression-free survival

Time frame: 4 months

Central Contacts

Tingbo Liang, MD

CONTACT

0086-13666676128 liangtingbo@zju.edu.cn

Data from ClinicalTrials.gov

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