Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

Launched by BIOTECH PHARMACEUTICAL CO., LTD. · Mar 19, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

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