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Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

This study is currently recruiting participants.
Verified April 2013 by Zhejiang Beta Pharma Inc.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01465243
First received: November 1, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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


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 , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Zhejiang Beta Pharma Inc.:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 6 months -1 year ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Health-Related Quality of Life (HR QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of Participants with adverse events and serious adverse events (SAEs) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465243

Locations
China, Beijing
307 Hospital of People's Liberation Army（PLA） Recruiting
Beijing, Beijing, China, 100071
Contact: Li Xi qing, M.D.     0086-010-66947161     liuxq@medmail.com.cn    
Principal Investigator: Li Xi qing, M.D.            
Sponsors and Collaborators
Zhejiang Beta Pharma Inc.
Investigators
Principal Investigator: Li Xi qing, M.D. 307 Hospital of People's Liberation Army（PLA）
  More Information

No publications provided

Responsible Party: Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier: NCT01465243     History of Changes
Other Study ID Numbers: BD-IC-IV01
Study First Received: November 1, 2011
Last Updated: April 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Beta Pharma Inc.:
Efficacy
Safety
EGFR-TKI
 phase IV
NSCLC
Dose escalation

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