Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

Phase 1

• Conditions: Solid Tumors
• Interventions: Drug: Nimotuzumab; Drug: irinotecan

• Registration Number: NCT02395068
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-10
• Study Start: 2012-11
• Primary Completion: 2014-11
• Study First Submitted: 2015-02-28
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-dose PK	Nimotuzumab	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.
Bioweekly fixed dose PK	irinotecan	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
Single-dose PK	irinotecan	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.
Weekly fixed dose	Nimotuzumab	Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks.
Bioweekly fixed dose PK	Nimotuzumab	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

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
PFS（Progression Free Survival）	The third weekend and Ninth weekend	Efficacy as measured by RECIST v1.1
ORR（Objective Response Rate）	The third weekend and Ninth weekend	Efficacy as measured by RECIST v1.1
DCR（Disease Control Rate）	The third weekend and Ninth weekend	Efficacy as measured by RECIST v1.1
Safety - AE measured by NCI CTCAE v 3.0	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.

Trial Locations

Locations (1)

Cancer Institute & Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China