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

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib of routine dose
Icotinib of high dose
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujian Hospital for Chest Tumors & Tuberculosis DiseasesRecruiting
  • Fujian Provincal HospitalRecruiting
  • Fujian Provincal Cancer HospitalRecruiting
  • The second hospital of Xiamen CityRecruiting
  • Hunan Provincal Cancer HospitalRecruiting
  • The Second People's Hospital of SichuanRecruiting
  • Sir Run Run Shaw HospitalRecruiting
  • The First Affiliated Hospital of Medical School of Zhejiang UniversityRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Zhejiang Traditional Chinese Medical Hospital
  • Zhejiang Hospital
  • Zhejiang Provincial People's HospitalRecruiting
  • Yinzhou People's HospitalRecruiting
  • Ningbo Medical Treatment Center Lihuili HospitalRecruiting
  • Taizhou Hospital of Zhejiang ProvinceRecruiting
  • The First Affiliated Hospital of Wenzhou Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Icotinib of Routine Dose

Icotinib of High Dose

Arm Description

Oral Drug icotinib 125 mg three times per day

Oral Drug icotinib 250 mg three times per day

Outcomes

Primary Outcome Measures

Progression Free Survival
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
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
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
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.

Full Information

First Posted
September 18, 2012
Last Updated
December 26, 2014
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01690390
Brief Title
Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icotinib of Routine Dose
Arm Type
Active Comparator
Arm Description
Oral Drug icotinib 125 mg three times per day
Arm Title
Icotinib of High Dose
Arm Type
Experimental
Arm Description
Oral Drug icotinib 250 mg three times per day
Intervention Type
Drug
Intervention Name(s)
Icotinib of routine dose
Other Intervention Name(s)
Icotinib, Comana, BPI-2009
Intervention Description
Icotinib of routine dose: 125 mg is administered orally three times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib of high dose
Other Intervention Name(s)
Icotinib, Comana, BPI-2009
Intervention Description
Icotinib: 250 mg is administered orally three times per day.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
15 months
Title
Transformation rate from stable disease to complete response or partial response
Description
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.
Time Frame
6 weeks
Title
Incidence rate of adverse events
Description
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.
Time Frame
40 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Yi Ping, M.D.
Phone
0086-13750881678
Email
zyp@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Yi Ping, M.D.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Hospital for Chest Tumors & Tuberculosis Diseases
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Qun, M.D.
Phone
0086-13860669883
First Name & Middle Initial & Last Name & Degree
Chen Qun, M.D.
Facility Name
Fujian Provincal Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cui Tongjian, M.D.
Phone
0086-13905920326
First Name & Middle Initial & Last Name & Degree
Cui Tongjian, M.D.
Facility Name
Fujian Provincal Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Cheng, M.D.
Phone
0086-13905010397
First Name & Middle Initial & Last Name & Degree
Huang Cheng, M.D.
Facility Name
The second hospital of Xiamen City
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361024
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Mingyao, M.D.
Phone
0086-13860166866
First Name & Middle Initial & Last Name & Degree
Ke Mingyao, M.D.
Facility Name
Hunan Provincal Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Lin, M.D.
Phone
0086-13706671349
First Name & Middle Initial & Last Name & Degree
Wu Lin, M.D.
Facility Name
The Second People's Hospital of Sichuan
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Jingrui, M.D.
Phone
0086-13551237583
First Name & Middle Initial & Last Name & Degree
Yu Jingrui, M.D.
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pan Minghong, M.D.
Phone
0086-57186006
Ext
922
Email
panhongming@tom.com
First Name & Middle Initial & Last Name & Degree
Pan Minghong, M.D.
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Jianying, M.D.
Phone
0086-13750881678
Email
drzjy@163.com
First Name & Middle Initial & Last Name & Degree
Zhou Jianying, M.D.
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Jianjin, M.D.
Phone
0086-13989889688
Email
hhjj@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Huang Jianjin, M.D.
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Yi Ping, M.D.
Phone
0086-13750881678
Email
zyp@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Zhang Yi Ping, M.D.
Facility Name
Zhejiang Traditional Chinese Medical Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310007
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Li Qin, M.D.
Phone
0086-13858039628
Email
llq99999@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Lu Li Qin, M.D.
Facility Name
Yinzhou People's Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Jianxin, M.D.
Phone
0086-13605741696
First Name & Middle Initial & Last Name & Degree
Guo Jianxin, M.D.
Facility Name
Ningbo Medical Treatment Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315046
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Weiyu, M.D.
Phone
0086-13805876129
First Name & Middle Initial & Last Name & Degree
Shen Weiyu, M.D.
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Wei, M.D.
Phone
0086-13606657129
First Name & Middle Initial & Last Name & Degree
Hu Wei, M.D.
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wenfeng, M.D.
Phone
0086-13968840592
First Name & Middle Initial & Last Name & Degree
Li Wenfeng, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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