Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

Biotech Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Nimotuzumab; Drug: irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT02395068

BT-PK-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Single-dose PK

Experimental group

Description:

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.

Treatment:

Drug: irinotecan

Drug: Nimotuzumab

Weekly fixed dose

Experimental group

Description:

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

Treatment:

Drug: Nimotuzumab

Bioweekly fixed dose PK

Experimental group

Description:

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

Treatment:

Drug: irinotecan

Drug: Nimotuzumab