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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
icotinib
Gemcitabine
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cancer Hospital of Harbin Medical University
  • Bethune First Hospital of Jilin University
  • First Affiliated Hospital of China Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

icotinib plus gemcitabine

Arm 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.

Outcomes

Primary Outcome Measures

The number of patients who suffer adverse events

Secondary Outcome Measures

Tumor response assessed by RECIST 1.1
Progression-free survival

Full Information

First Posted
October 28, 2014
Last Updated
May 21, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02278458
Brief Title
Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
Official Title
Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
icotinib plus gemcitabine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
icotinib
Other Intervention Name(s)
Commana
Intervention Description
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
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
Primary Outcome Measure Information:
Title
The number of patients who suffer adverse events
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Tumor response assessed by RECIST 1.1
Time Frame
3 months
Title
Progression-free survival
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqiao Zhang, MD
Organizational Affiliation
Cancer Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Bethune First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
150081
Country
China
Facility Name
First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
150081
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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