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Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465243
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : February 17, 2014
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Icotinib Phase 4

Detailed Description:
Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy
Study Start Date : September 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Icotinib
This is a single arm study.
Drug: Icotinib
125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)
Other Name: BPI-2009, Conmana

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 6-12 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months -1 year ]
  2. Objective response rate [ Time Frame: 3-6 months ]
  3. Time to progression [ Time Frame: 3-6 months ]
  4. Health-Related Quality of Life (HR QOL) [ Time Frame: 1 year ]
  5. Number of Participants with adverse events and serious adverse events (SAEs) [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Confirmed NSCLC with Histology or cytology; advanced (IIIb/IV).
  2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
  3. Measurable, evaluable disease outside of a radiation port.

Exclusion Criteria:

  1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
  2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465243

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China, Beijing
307 Hospital of People's Liberation Army(PLA)
Beijing, Beijing, China, 100071
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
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Principal Investigator: Li Xi qing, M.D. 307 Hospital of People's Liberation Army(PLA)

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Responsible Party: Betta Pharmaceuticals Co., Ltd. Identifier: NCT01465243    
Other Study ID Numbers: BD-IC-IV01
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: February 2014
Keywords provided by Betta Pharmaceuticals Co., Ltd.:
phase IV
Dose escalation
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases