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

• Sponsor: Biotech Pharmaceutical Co., Ltd. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02395016
• Collaborator: NanJing PLA 81 Hospital (Other), Fudan University (Other)
• Enrollment: 276
• Locations: 25
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 11
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2015
• Anticipated Primary Completion Date: Mar 1, 2017
• Anticipated Study Completion Date: Mar 1, 2018

Arms and Interventions

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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. overall survival（OS） [up to 3 years]

Secondary Outcome Measures

1. Time to Progression（TTP） [up to 3 years]

2. Progression Free Survival（PFS） [up to 3 years]

3. Objective Response Rate（ORR） [Once every eight weeks，up to 5.4 months]

   Appeared efficacy from the beginning until proven disease progression

4. Disease Control Rate（DCR） [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） [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) [Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China	233004
2	Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230601
3	Beijing Union Medical College Hospital	Beijing	Beijing	China	100005
4	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	Beijing	China	100021
5	PLA General Hospital (301 Hospital)	Beijing	Beijing	China	100039
6	Affiliated Hospital of Military Medical Sciences	Beijing	Beijing	China	100071
7	Beijing Cancer Hospital	Beijing	Beijing	China	100142
8	Fuzhou General Hospital of Nanjing Military Region	Fuzhou	Fujian	China	350000
9	Fujian Provincial Tumor Hospital	Fuzhou	Fujian	China	350014
10	Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150040
11	Jiangyin City People's Hospital	Jiangyin	Jiangsu	China	214400
12	Jiangsu Province Tumor Hospital	Nanjing	Jiangsu	China	210009
13	Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	China	116027
14	Shanghai Jiaotong University Affiliated Ruijin Hospital	Shanghai	Shanghai	China	200025
15	Shanghai Fudan University Cancer Hospital	Shanghai	Shanghai	China	200032
16	Shanghai Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
17	Shanghai Huashan Hospital, Fudan University	Shanghai	Shanghai	China	200040
18	First People's Hospital Cancer Center, Shanghai Jiaotong University	Shanghai	Shanghai	China	200080
19	Shanghai Changhai Hospital	Shanghai	Shanghai	China	200433
20	Affiliated Xijing Hospital, Fourth Military Medical University	Xi'an	Shanxi	China	710032
21	General Hospital of Chengdu Military Region	Chendu	Sichuan	China	610083
22	First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003
23	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
24	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang	China	310016
25	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Biotech Pharmaceutical Co., Ltd.
• NanJing PLA 81 Hospital
• Fudan University

Investigators

• Principal Investigator: shukui qin, MD, PHD, 81th Hospital of PLA
• Principal Investigator: jin li, MD, PHD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotech Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02395016
• Other Study ID Numbers: BPL-Nim-PC-1
• First Posted: Mar 20, 2015
• Last Update Posted: Aug 3, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Nimotuzumab

Study Results

No Results Posted as of Aug 3, 2015