Status:
UNKNOWN
A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Metastatic Solid Tumors
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
This study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;
- Patients failed the standard anti-tumor therapy or don't have standard regimen;
- At least one measurable lesion;
- At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;
- Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);
- ECOG performance status 0-1;
- Life expectancy ≥ 3 months;
- Adequate hematologic function: ANC ≥ 1.5 × 10\^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10\^9 /L;
- Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN);
- Adequate renal function: creatinine ≤ 1 × ULN;
- Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
- Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.
Exclusion
- HCV, TP or HIV antibody positive;
- Previously received anti-VEGF protein drugs, such as bevacizumab;
- Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;
- Active hepatitis B infection;
- Evidence of serious infection;
- Symptomatic brain metastases;
- Patients with proteinuria at screening (urine protein ≥ 1+);
- History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
- Serious non-healing wounds, ulcers or fractures;
- Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment;
- Active bleeding within 3 months prior to enrollment;
- Bleeding diathesis or coagulation disorder;
- History of arterial or venous thrombosis;
- History of myocardial infarction or stroke within 6 months prior to enrollment;
- Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mmHg);
- Pregnant and lactating women;
- Known allergies to any excipient in the study drug;
- Patients with alcohol or drug dependence;
- Participation in other clinical trials within 4 weeks before enrollment.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01847118
Start Date
April 1 2013
End Date
November 1 2015
Last Update
March 24 2015
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China