Study Stopped
Accrual limitations
Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
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
1 other identifier
interventional
20
1 country
1
Brief Summary
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 nonsmall-cell-lung-cancer
Started Feb 2013
Longer than P75 for phase_4 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 22, 2015
May 1, 2015
2.8 years
October 31, 2012
May 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
4.5 months
Secondary Outcomes (3)
Overall survival
12 months
Tumor response
6 weeks
Adverse Events
18 months
Study Arms (1)
Icotinib
EXPERIMENTALIcotinib will be administered 250 mg one time by month, 3 times per day.
Interventions
Icotinib will be administered 250 mg one time by month, 3 times per day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital, Central-South Univercity
Changsha, Hunan, 410008, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hu Chengping, M.D.
Xiangya Hospital, Central-South Univercity
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 2, 2012
Study Start
February 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
May 22, 2015
Record last verified: 2015-05