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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Betta Pharmaceuticals Co.,Ltd..
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01690390
First received: September 18, 2012
Last updated: December 26, 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
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 ]
    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 ]
    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 ]
    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 ]
    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: July 2016
Estimated Primary Completion Date: December 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
China, Fujian
Fujian Hospital for Chest Tumors & Tuberculosis Diseases
Fuzhou, Fujian, China, 350000
Fujian Provincal Hospital
Fuzhou, Fujian, China, 350001
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, China, 350014
The second hospital of Xiamen City
Xiamen, Fujian, China, 361024
China, Hunan
Hunan Provincal Cancer Hospital
Changsha, Hunan, China, 410006
China, Sichuan
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China, 610041
China, Zhejiang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, China, 310000
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, China, 310006
Zhejiang Hospital
Hangzhou, Zhejiang, China, 310007
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Yinzhou People's Hospital
Ningbo, Zhejiang, China, 315040
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, China, 315046
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Zhang Yi Ping, M.D. Zhejiang Cancer Hospital
  More Information

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: December 26, 2014

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

ClinicalTrials.gov processed this record on January 19, 2017