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A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02395016
Recruitment Status : Unknown
Verified June 2015 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 20, 2015
Last Update Posted : August 3, 2015
Sponsor:
Collaborators:
NanJing PLA 81 Hospital
Fudan University
Information provided by (Responsible Party):
Biotech Pharmaceutical Co., Ltd.

Brief Summary:
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival(OS)of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: nimotuzumab Drug: Gemcitabine Other: Placebo Phase 3

Detailed Description:
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival(OS)of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer.Secondary objectives include time to progression(TTP),progression-free survival(PFS),Objective Response Rate(ORR),Disease Control Rate(DCR),Clinical Benefit Response(CBR)and safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Double-blind, Multi-center Clinical Study of Nimotuzumab Combinated With Gemcitabine Contrast to Placebo Combinated With Gemcitabine in K-RAS Wild-type,Locally Advanced and Metastatic Pancreatic Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nimotuzumab and Gemcitabine

nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Drug: nimotuzumab
nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.
Other Name: Taixinsheng

Drug: Gemcitabine
Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Placebo Comparator: Placebo and Gemcitabine

placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Drug: Gemcitabine
Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Other: Placebo
Placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.




Primary Outcome Measures :
  1. overall survival(OS) [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Time to Progression(TTP) [ Time Frame: up to 3 years ]
  2. Progression Free Survival(PFS) [ Time Frame: up to 3 years ]
  3. Objective Response Rate(ORR) [ Time Frame: Once every eight weeks,up to 5.4 months ]
    Appeared efficacy from the beginning until proven disease progression

  4. Disease Control Rate(DCR) [ Time Frame: Once every eight weeks,up to 5.4 months ]
    The number of cases in remission after being treated and the disease stabilized accounts the total percentage of the number of evaluable patients

  5. Clinical Benefit Response(CBR) [ Time Frame: Once a week,up to 5.4 months ]
    Only evaluated the symptomatic patients in the study

  6. To determine the safety of the treatment with Nimotuzumab and Gemcitabine (NCI Common Terminology Criteria for Adverse Events v4.03) [ Time Frame: Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age:18-75 years old
  • KPS≥60
  • Histological or cytological diagnosis that are unsuitable for radical radiotherapy or surgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (≥6 months to the last adjuvant chemotherapy)
  • Has at least one objective measurable lesion can be evaluated according to Response Evaluation Criteria in Solid Tumors1.1(Helical CT examination of the longest diameter of target lesions≥10mm, such as lymph node metastasis only need the shortest path ≥15mm)
  • Life expectancy ≥12 weeks
  • K-RAS tumor tissue detected as the wild-type
  • Aspartate transaminase(AST)/aminotransferase(ALT)≤2.5×ULN,AST /ALT≤5×ULN(if liver metastases);Total bilirubin≤2×ULN,Total bilirubin≤3×ULN(if liver metastases);Absolute neutrophil count≥1.5×109/L;Blood platelet≥100×109/L;Hemoglobin≥90 g/L;Creatinine clearance≥60ml/min
  • Volunteered to participate this study, written informed consent and has a good compliance
  • Patients of childbearing age and their spouses are willing to take contraceptive measures

Exclusion Criteria:

  • Before this study had received the following treatments:As a means of anti-tumor palliative chemotherapy and molecular targeted therapy.Target lesion had received radiotherapy without progression.within 4 weeks or be participating in clinical trials of other therapeutic/ interventionist clinical trial.
  • Undergone major surgery within 4 weeks.
  • The brain metastasis or leptomeningeal metastasis.
  • Has a history of malignancy other than the pancreatic cancer (except for the cured cervix in situ or basal cell carcinoma, and a five-year cure other cancers).
  • The merger has symptoms of ascites and requires clinical treatment. Accompanied by other serious disease, including but not limited:Congestive heart failure which is difficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia, Uncontrolled moderate to severe hypertension(systolic blood pressure(SBP)>160 mm Hg or diastolic blood pressure(DBP)>100 mm Hg).Active infection.Diabetes which is difficult to control.Has mental illness which impacts the informed consent and / or compliance program.HIV infection.There is serious illness that other researchers consider is unsuitable to participate this study.
  • Known allergy to anti-EGFR antibody formulations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395016


Contacts
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Contact: shukui qin, MD, PHD 025-80864541 qinsk@csco.org.cn

Locations
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China, Anhui
First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China, 233004
Contact: qiong wu, PhD         
Principal Investigator: qiong wu, PhD         
Second Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230601
Contact: zhendong chen, PhD         
Principal Investigator: zhendong chen, PhD         
China, Beijing
Beijing Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100005
Contact: chunmei bai, PhD         
Principal Investigator: chunmei bai, PhD         
Chinese Academy of Medical Sciences Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100021
Contact: lin yang, PhD         
Principal Investigator: lin yang, PhD         
PLA General Hospital (301 Hospital) Recruiting
Beijing, Beijing, China, 100039
Contact: yi hu, PhD         
Principal Investigator: yi hu, PhD         
Affiliated Hospital of Military Medical Sciences Recruiting
Beijing, Beijing, China, 100071
Contact: jianming xu, PhD         
Principal Investigator: jianming xu, PhD         
Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100142
Contact: chunyi hao, PhD         
Principal Investigator: chunyi hao, PhD         
China, Fujian
Fuzhou General Hospital of Nanjing Military Region Not yet recruiting
Fuzhou, Fujian, China, 350000
Contact: xuenong ouyang, PhD         
Principal Investigator: xuenong ouyang, PhD         
Fujian Provincial Tumor Hospital Not yet recruiting
Fuzhou, Fujian, China, 350014
Contact: jianwei yang, PhD         
Principal Investigator: jianwei yang, PhD         
China, Heilongjiang
Cancer Hospital of Harbin Medical University Not yet recruiting
Harbin, Heilongjiang, China, 150040
Contact: yuxian bai, PhD         
Principal Investigator: yuxian bai, PhD         
China, Jiangsu
Jiangyin City People's Hospital Not yet recruiting
Jiangyin, Jiangsu, China, 214400
Contact: qiong wang, PhD         
Principal Investigator: qiong wang, PhD         
Jiangsu Province Tumor Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: jia chen, PhD         
Principal Investigator: jia chen, PhD         
China, Liaoning
Second Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116027
Contact: yang zhang, PhD         
Principal Investigator: yang zhang, PhD         
China, Shanghai
Shanghai Jiaotong University Affiliated Ruijin Hospital Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: jun zhang, PhD         
Principal Investigator: jun zhang, PhD         
Shanghai Fudan University Cancer Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: zhiqiang meng, PhD         
Principal Investigator: zhiqiang meng, PhD         
Shanghai Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: tianshu liu, PhD         
Principal Investigator: tianshu liu, PhD         
Shanghai Huashan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: deliang fu, PhD         
Principal Investigator: deliang fu, PhD         
First People's Hospital Cancer Center, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200080
Contact: liwei wang, PhD         
Principal Investigator: liwei wang, PhD         
Shanghai Changhai Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: zhaoshen li, PhD         
Principal Investigator: zhaoshen li, PhD         
China, Shanxi
Affiliated Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shanxi, China, 710032
Contact: wenchao liu, PhD         
Principal Investigator: wenchao liu, PhD         
China, Sichuan
General Hospital of Chengdu Military Region Not yet recruiting
Chendu, Sichuan, China, 610083
Contact: tao zhang, PhD         
China, Zhejiang
First Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: nong xu, PhD         
Principal Investigator: nong xu, PhD         
Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: ying yuan, PhD         
Principal Investigator: ying yuan, PhD         
Sir Run Run Shaw Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310016
Contact: hongming pan, PhD         
Principal Investigator: hongming pan, PhD         
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310022
Contact: haijun zhong, PhD         
Principal Investigator: haijun zhong, PhD         
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
NanJing PLA 81 Hospital
Fudan University
Investigators
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Principal Investigator: shukui qin, MD, PHD 81th Hospital of PLA
Principal Investigator: jin li, MD, PHD Fudan University

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Responsible Party: Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02395016     History of Changes
Other Study ID Numbers: BPL-Nim-PC-1
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Nimotuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological