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Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

Primary Purpose

Non-small Cell Lung Cancer

Status
Suspended
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Icotinib
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.
  • Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.
  • Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

  • Allergic to icotinib.
  • Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Sites / Locations

  • Xiangya Hospital, Central-South Univercity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib

Arm Description

Icotinib will be administered 250 mg one time by month, 3 times per day.

Outcomes

Primary Outcome Measures

Progression-free survival
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.

Secondary Outcome Measures

Overall survival
Overall survival is a duration from the date that first dose is given to the date of death.
Tumor response
Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.
Adverse Events
Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.

Full Information

First Posted
October 31, 2012
Last Updated
May 21, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01720901
Brief Title
Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
Official Title
An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Suspended
Why Stopped
Accrual limitations
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 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
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Detailed Description
This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib will be administered 250 mg one time by month, 3 times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Conmana, BPI-2009
Intervention Description
Icotinib will be administered 250 mg one time by month, 3 times per day.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
Time Frame
4.5 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is a duration from the date that first dose is given to the date of death.
Time Frame
12 months
Title
Tumor response
Description
Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.
Time Frame
6 weeks
Title
Adverse Events
Description
Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.
Time Frame
18 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: Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC. Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors. Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: Allergic to icotinib. Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Chengping, M.D.
Organizational Affiliation
Xiangya Hospital, Central-South Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital, Central-South Univercity
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China

12. IPD Sharing Statement

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Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

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