Combination Of Icotinib And Gemcitabine As First-line Treatment In Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: icotinib
DRUG: Gemcitabine

BD-IC-IV48

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-12-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-07-14
First Submitted that Met QC Criteria 2013-12-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-07-15
First Posted (ESTIMATED) 2013-12-31	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 r	DRUG: 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 DRUG: Gemcitabine Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 r

DRUG: 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

DRUG: Gemcitabine

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

Primary Outcome Measures	Measure Description	Time Frame
The number of patients who suffer adverse events		24 months

Secondary Outcome Measures	Measure Description	Time Frame
Tumor response assessed by RECIST 1.1		3 months
Progression-free survival		4 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tingbo Liang, MD

Phone Number: 0086-13666676128

Email: liangtingbo@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Tingbo Liang, MD, Second Affiliated Hospital of Zhejiang Univercity School of Medcine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record