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Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02395068
Recruitment Status : Unknown
Verified October 2012 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Biotech Pharmaceutical Co., Ltd.

Brief Summary:
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are ongoing all over the investigators' country. The main purpose of this study is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Nimotuzumab Drug: irinotecan Phase 1

Detailed Description:
This is a single-centered, non-randomized and open-labeled Clinical Pharmacokinetics Study of Nimotuzumab in patients with solid tumors. The test includes 3 dose groups, namely Single dose group, Multiple single-week dose group and Multiple bi week dose group, to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics Study of Nimotuzumab Single-dose and Multiple-dose in Combination With Irinotecan in Patients With Solid Tumors
Study Start Date : November 2012
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-dose PK
single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation. 1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle.
Drug: Nimotuzumab
single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation;Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks;600mg, administered once every 2 weeks for 8 weeks.
Other Name: Taixinsheng

Drug: irinotecan

Single-dose PK:1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle.

Bioweekly fixed dose PK:Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h

Other Name: CPT-11

Experimental: Weekly fixed dose
Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks.
Drug: Nimotuzumab
single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation;Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks;600mg, administered once every 2 weeks for 8 weeks.
Other Name: Taixinsheng

Experimental: Bioweekly fixed dose PK
Nimotuzumab 600mg, administered once every 2 weeks for 8 weeks. Dosing regimens can be adjusted according to the results of preliminary experiments. Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h
Drug: Nimotuzumab
single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation;Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks;600mg, administered once every 2 weeks for 8 weeks.
Other Name: Taixinsheng

Drug: irinotecan

Single-dose PK:1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle.

Bioweekly fixed dose PK:Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h

Other Name: CPT-11




Primary Outcome Measures :
  1. Pharmacokinetics of Nimotuzumab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors: Single dose:Tmax,Cmax, AUC,Vc,t1/2α,t1/2β,CL. Multiple dose:Tmax,Css-min,Css-max,Css-a,t1/2β,CL,AUCss,DF. [ Time Frame: up to 9 weeks ]

    The measure is a composite.The measure of single dose:Tmax,Cmax, AUC,Vc,t1/2α,t1/2β,CL.

    The measure of multiple dose:Tmax,Css-min,Css-max,Css-a,t1/2β,CL,AUCss,DF.



Secondary Outcome Measures :
  1. Safety - AE measured by NCI CTCAE v 3.0 [ Time Frame: Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days ]
    Safety evaluations included adverse events and changes in laboratory data.Adverse events were descriptive statistics, lists the event occurred, the duration, severity, and drug relationship, as well as its outcome.

  2. ORR(Objective Response Rate) [ Time Frame: The third weekend and Ninth weekend ]
    Efficacy as measured by RECIST v1.1

  3. DCR(Disease Control Rate) [ Time Frame: The third weekend and Ninth weekend ]
    Efficacy as measured by RECIST v1.1

  4. PFS(Progression Free Survival) [ Time Frame: The third weekend and Ninth weekend ]
    Efficacy as measured by RECIST v1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Confirmed by pathology and / or cytology diagnosis in patients with advanced solid tumors
  2. Failure of first-line or multi-line chemotherapy and be suitable for irinotecan therapy
  3. Age 18-70 years, both genders at enrollment
  4. ECOG 0 to 1
  5. Adequate bone marrow function
  6. Recover from the toxicity of previous treatment
  7. At least one measurable site of disease as defined by at least 20mm in greatest dimension by CT or 10mm in greatest dimension by SCT/MRI
  8. Male or female with fertility in the trial are willing to take contraceptive measures
  9. Estimated life expectancy of 3 months or greater
  10. All patients signed written informed consent

Exclusion criteria:

  1. Have previously received EGFR-targeted therapy
  2. Current treatment on other effective programs
  3. Participated in other clinical trial within 4 weeks after enrollment
  4. Nervous system symptoms caused by brain metastases need to apply steroidal anti-edema medications to control
  5. Persistent uncontrollable diarrhea CTCAE 2 level and above (4-6 times daily)
  6. Complete or incomplete intestinal obstruction
  7. Need to drainage pleural effusion and ascites
  8. Drug addiction and other adverse long-term alcoholics, as well as AIDS patients
  9. Occurred myocardial infarction within 6 months
  10. Diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by Chest CT
  11. Severe or uncontrolled complications, such as infection required systemic treatment,fever(≥38℃),congestive heart failure,diabetes or hypertension that can not be controlled by drugs and other complications that may interfere with drug efficacy
  12. Drug allergy(≥CTCAE 3.0), such as shock or allergy symptoms, especially allergic to similar drugs in the past and severe hypersensitivity to polysorbate eighty-containing drugs
  13. Uncontrollable seizures or loss of insight because of psychosis
  14. Female patient is pregnant, breastfeeding, or of childbearing potential but not take contraceptive measures
  15. Male patient who want his spouse to be pregnant during the trial
  16. Researchers believe that should not participate in this trial

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): NCT02395068


Locations
China, Beijing
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jinwan Wang, PhD,MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party: Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02395068     History of Changes
Other Study ID Numbers: BT-PK-001
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: October 2012

Keywords provided by Biotech Pharmaceutical Co., Ltd.:
Pharmacokinetics
Nimotuzumab
Safety
Effcacy
Irinotecan

Additional relevant MeSH terms:
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action