Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
This study is currently recruiting participants.
Verified April 2013 by Zhejiang Beta Pharma Inc.
Sponsor:
Zhejiang Beta Pharma Inc.
Information provided by (Responsible Party):
Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01690390
First received: September 18, 2012
Last updated: April 26, 2013
Last verified: April 2013
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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 ,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 Zhejiang Beta Pharma Inc.:
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: | May 2014 (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:
|
|
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:
|
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
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 | |
| 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. | |
| 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. | |
| 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. | |
| 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 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. | |
| Zhejiang Traditional Chinese Medical Hospital | Active, not recruiting |
| Hangzhou, Zhejiang, China, 310006 | |
| Zhejiang Hospital | Active, not recruiting |
| Hangzhou, Zhejiang, China, 310007 | |
| Ningbo Medical Treatment Center Lihuili Hospital | Recruiting |
| Ningbo, Zhejiang, China, 315046 | |
| Contact: Shen Weiyu, M.D. 0086-13805876129 | |
| Principal Investigator: Shen Weiyu, M.D. | |
| Yinzhou People's Hospital | Recruiting |
| Ningbo, Zhejiang, China, 315040 | |
| Contact: Guo Jianxin, M.D. 0086-13605741696 | |
| Principal Investigator: Guo Jianxin, 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
Zhejiang Beta Pharma Inc.
Investigators
| Principal Investigator: | Zhang Yi Ping, M.D. | Zhejiang Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Zhejiang Beta Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01690390 History of Changes |
| Other Study ID Numbers: | BD-IV-43 |
| Study First Received: | September 18, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | China: Food and Drug Administration |
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 May 16, 2013