First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
This study is currently recruiting participants.
Verified April 2013 by Zhejiang Beta Pharma Inc.
Sponsor:
Zhejiang Beta Pharma Inc.
Information provided by (Responsible Party):
Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01646450
First received: July 17, 2012
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Icotinib |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation |
Resource links provided by NLM:
Further study details as provided by Zhejiang Beta Pharma Inc.:
Primary Outcome Measures:
- Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Secondary Outcome Measures:
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.
- Objective response rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Icotinib
Icotinib: 125mg, oral administration, three times per day.
|
Drug: Icotinib
Icotinib: 125mg, oral administration, three times per day.
Other Names:
|
Detailed Description:
A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
- Primary endpoint to assess progression-free survival
- Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
Eligibility| Ages Eligible for Study: | 70 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
- Positive EGFR Mutation.
- No previous systemic anticancer therapy.
- Male and female patients aged over 70 years.
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- Provision of written informed consent.
Exclusion Criteria:
- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646450
Contacts
| Contact: Han Baohui, MD | 0086-021-62808887 |
Locations
| China, Shanghai | |
| Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity | Recruiting |
| Shanghai, Shanghai, China, 200030 | |
| Contact: Han Baohui, MD 0086-021-62808887 | |
Sponsors and Collaborators
Zhejiang Beta Pharma Inc.
Investigators
| Principal Investigator: | Han Baohui, MD | Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity |
More Information
No publications provided
| Responsible Party: | Zhejiang Beta Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01646450 History of Changes |
| Other Study ID Numbers: | BD-IC-IV20 |
| Study First Received: | July 17, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang Beta Pharma Inc.:
|
NSCLC EGFR Mutation Elder patients |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013