Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

NCT ID: NCT02395068

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Weekly fixed dose

Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks.

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Taixinsheng; CPT-11

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinwan Wang, PhD，MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BT-PK-001

Identifier Type: -

Identifier Source: org_study_id