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

Phase 1

• Conditions: Pancreatic Cancer
• Interventions: Drug: icotinib; Drug: Gemcitabine

• Registration Number: NCT02024633
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-26
• Study First Posted: 2013-12-31
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-15
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
icotinib plus gemcitabine	icotinib	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.
icotinib plus gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
The number of patients who suffer adverse events	24 months

Secondary Outcome Measures

Name	Time	Method
Tumor response assessed by RECIST 1.1	3 months
Progression-free survival	4 months

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang Univercity School of Medcine; 🇨🇳 Hangzhou, China