Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

Solid Tumors Clinical Trial

Official title:

Pharmacokinetics Study of Nimotuzumab Single-dose and Multiple-dose in Combination With Irinotecan in Patients With Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02395068
• Other study ID #: BT-PK-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 28, 2015
• Last updated: August 17, 2015
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2012
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Nimotuzumab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors: Single dose:Tmax,Cmax, AUC,Vc,t1/2a,t1/2ß,CL. Multiple dose:Tmax,Css-min,Css-max,Css-a,t1/2ß,CL,AUCss,DF.	The measure is a composite.The measure of single dose:Tmax,Cmax, AUC,Vc,t1/2a,t1/2ß,CL.; The measure of multiple dose:Tmax,Css-min,Css-max,Css-a,t1/2ß,CL,AUCss,DF.	up to 9 weeks	No
Secondary	Safety - AE measured by NCI CTCAE v 3.0	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.	Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days	Yes
Secondary	ORR(Objective Response Rate)	Efficacy as measured by RECIST v1.1	The third weekend and Ninth weekend	No
Secondary	DCR(Disease Control Rate)	Efficacy as measured by RECIST v1.1	The third weekend and Ninth weekend	No
Secondary	PFS(Progression Free Survival)	Efficacy as measured by RECIST v1.1	The third weekend and Ninth weekend	No