Overview

This trial is active, not recruiting.

Condition solid tumors
Treatments nimotuzumab, irinotecan
Phase phase 1
Target EGFR
Sponsor Biotech Pharmaceutical Co., Ltd.
Start date November 2012
End date November 2014
Trial size 40 participants
Trial identifier NCT02395068, BT-PK-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
nimotuzumab Taixinsheng
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.
irinotecan CPT-11
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
(Experimental)
Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks.
nimotuzumab Taixinsheng
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.
(Experimental)
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
nimotuzumab Taixinsheng
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.
irinotecan CPT-11
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
ORR(Objective Response Rate)
time frame: The third weekend and Ninth weekend
DCR(Disease Control Rate)
time frame: The third weekend and Ninth weekend
PFS(Progression Free Survival)
time frame: The third weekend and Ninth weekend

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Pharmacokinetics Study of Nimotuzumab Single-dose and Multiple-dose in Combination With Irinotecan in Patients With Solid Tumors
Principal investigator Jinwan Wang, PhD,MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Biotech Pharmaceutical Co., Ltd..