Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Betta Pharmaceuticals Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01690390
First received: September 18, 2012
Last updated: June 25, 2014
Last verified: December 2013
  Purpose

The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.


Condition Intervention Phase
NSCLC
Drug: Icotinib of routine dose
Drug: Icotinib of high dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease

Resource links provided by NLM:


Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

  • Transformation rate from stable disease to complete response or partial response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.

  • Incidence rate of adverse events [ Time Frame: 40 months ] [ Designated as safety issue: Yes ]
    Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.


Estimated Enrollment: 180
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Icotinib of Routine Dose
Oral Drug icotinib 125 mg three times per day
Drug: Icotinib of routine dose
Icotinib of routine dose: 125 mg is administered orally three times per day.
Other Names:
  • Icotinib
  • Comana
  • BPI-2009
Experimental: Icotinib of High Dose
Oral Drug icotinib 250 mg three times per day
Drug: Icotinib of high dose
Icotinib: 250 mg is administered orally three times per day.
Other Names:
  • Icotinib
  • Comana
  • BPI-2009

Detailed Description:

This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
  • No previous targeted treatment such as gefitinib, erlotinib.
  • With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria
  • WHO performance status(PS)<= 2
  • N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
  • Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

  • Allergic to icotinib
  • Patients with metastatic brain tumors with symptoms.
  • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690390

Contacts
Contact: Zhang Yi Ping, M.D. 0086-13750881678 zyp@medmail.com.cn

Locations
China, Fujian
Fujian Provincal Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
Contact: Huang Cheng, M.D.    0086-13905010397      
Principal Investigator: Huang Cheng, M.D.         
Fujian Provincal Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Cui Tongjian, M.D.    0086-13905920326      
Principal Investigator: Cui Tongjian, M.D.         
Fujian Hospital for Chest Tumors & Tuberculosis Diseases Recruiting
Fuzhou, Fujian, China, 350000
Contact: Chen Qun, M.D.    0086-13860669883      
Principal Investigator: Chen Qun, M.D.         
The second hospital of Xiamen City Recruiting
Xiamen, Fujian, China, 361024
Contact: Ke Mingyao, M.D.    0086-13860166866      
Principal Investigator: Ke Mingyao, M.D.         
China, Hunan
Hunan Provincal Cancer Hospital Recruiting
Changsha, Hunan, China, 410006
Contact: Wu Lin, M.D.    0086-13706671349      
Principal Investigator: Wu Lin, M.D.         
China, Sichuan
The Second People's Hospital of Sichuan Recruiting
Chengdu, Sichuan, China, 610041
Contact: Yu Jingrui, M.D.    0086-13551237583      
Principal Investigator: Yu Jingrui, M.D.         
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Pan Minghong, M.D.    0086-57186006 ext 922    panhongming@tom.com   
Principal Investigator: Pan Minghong, M.D.         
Zhejiang Traditional Chinese Medical Hospital Active, not recruiting
Hangzhou, Zhejiang, China, 310006
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Lu Li Qin, M.D.    0086-13858039628    llq99999@yahoo.com.cn   
Principal Investigator: Lu Li Qin, M.D.         
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Huang Jianjin, M.D.    0086-13989889688    hhjj@medmail.com.cn   
Principal Investigator: Huang Jianjin, M.D.         
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zhang Yi Ping, M.D.    0086-13750881678    zyp@medmail.com.cn   
Principal Investigator: Zhang Yi Ping, M.D.         
Zhejiang Hospital Active, not recruiting
Hangzhou, Zhejiang, China, 310007
The First Affiliated Hospital of Medical School of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zhou Jianying, M.D.    0086-13750881678    drzjy@163.com   
Principal Investigator: Zhou Jianying, M.D.         
Yinzhou People's Hospital Recruiting
Ningbo, Zhejiang, China, 315040
Contact: Guo Jianxin, M.D.    0086-13605741696      
Principal Investigator: Guo Jianxin, M.D.         
Ningbo Medical Treatment Center Lihuili Hospital Recruiting
Ningbo, Zhejiang, China, 315046
Contact: Shen Weiyu, M.D.    0086-13805876129      
Principal Investigator: Shen Weiyu, M.D.         
Taizhou Hospital of Zhejiang Province Recruiting
Taizhou, Zhejiang, China, 317000
Contact: Hu Wei, M.D.    0086-13606657129      
Principal Investigator: Hu Wei, M.D.         
The First Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Li Wenfeng, M.D.    0086-13968840592      
Principal Investigator: Li Wenfeng, M.D.         
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Zhang Yi Ping, M.D. Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01690390     History of Changes
Other Study ID Numbers: BD-IV-43
Study First Received: September 18, 2012
Last Updated: June 25, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014