EUCTR2008-006780-37-DE进行中（未招募）1 期
A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination with Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients with Previously Untreated Advanced (Stage IIIb or IV) Non-Small Cell Lung cancer
Biothera0 个研究点开始时间: 2008年12月11日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis and Main Criteria for Inclusion in the Study:
- •Inclusion Criteria
- •To be considered eligible to participate in the study, a subject must meet all of the inclusion criteria listed below.
- •The subject:
- •1. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review
- •Board/Ethics Committee (IRB/EC);
- •2. Is between the ages of 18 and 75 years old, inclusive;
- •3. Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage
- •IV non-small cell lung cancer;
- •4. Has non-squamous, non-small cell lung cancer
- •5. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to
- •RECIST version 1.0;
- •6. Has an ECOG performance status of 0 or 1;
- •7. Has a life expectancy of > 3 months;
- •8. Has adequate hematologic function as evidenced by:
- •a. ANC = 1,500/µL
- •b. PLT = 100,000/µL
- •c. HGB = 9 g/dL
- •obtained within 1 week prior to the first dose of study medication;
- •9. Has adequate renal function as evidenced by:
- •a. Serum creatinine = 1.5 X the upper limit of normal (ULN) for the reference lab
- •b. Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1
- •If urine dipstick is = 1+, then urine protein excretion must be = 500 mg over a 24 hour collection
- •obtained within 1 week prior to the first dose of study medication;
- •10. Has adequate hepatic function as evidenced by:
- •a. Serum total bilirubin = 1.0 mg/dL
- •b. AST = 2.5X ULN for the reference lab (= 5X ULN for subjects with known hepatic metastases)
- •c. ALT = 2.5X ULN for the reference lab (= 5X ULN for subjects with known hepatic metastases)
- •obtained within 1 week prior to the first dose of study medication;
- •11. Has adequate coagulation function as evidenced by:
- •a. INR = 1.5 X ULN for the reference lab
- •b. PTT = 1.5 X ULN for the reference lab obtained within 1 week prior to the first dose of study medication;
- •12. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form
- •of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below.
- •The subject:
- •1. Has received prior systemic chemotherapy at any time for lung cancer;
- •2. Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3
- •weeks of Day 1;
- •3. Has a known hypersensitivity to baker’s yeast, or has an active yeast infection;
- •4. Has had previous exposure to Betafectin® or Imprime PGG;
- •5. Has an active infection;
- •6. Presents with any of the following medical diagnoses/conditions at the time of screening:
- •a. Central nervous system (CNS) metastases
- •b. Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for
- •adequate control
- •c. Peripheral neuropathy = grade 2 from any cause
- •d. Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
- •e. Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other
- •clinical diagnosis, ongoing or intercurrent illness that in the physician’s opinion could interfere
- •with participation
- •7. Has a history of any of the following medical diagnoses/conditions:
- •a. Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic
- •attack or cerebral infarction
- •b. Deep vein thrombosis within 1 year prior to screening
- •c. Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting
- •cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
- •d. Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intraepithelial
- •neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
- •8. Has a known hypersensitivity to bevacizumab, murine proteins, or any component of bevacizumab;
- •9. Has a know sensitivity to polyethoxylated castor oil;
- •10. Has previously received treatment with bevacizumab;
- •11. Has had surgery within 4 weeks of Day 1 or needle or open biopsy within 1 week of Day 1;
- •12. Has a non-healing wound or gastric ulcer;
- •13. Has a non-healed bone fracture;
- •14. Is receiving systemic anti-coagulation therapy (e.g., dipyridalmole (Persantine®), ticlopidine (Ticlid®),
- •clopidogrel (Plavix®) and /or cilostazol (Pletal®);
- •15. Is receiving chronic daily treatment with aspirin (>100 mg/day) or other nonsteroidal anti-inflammatory
- •agents known to inhibit platelet function within 1 week of Day 1;
- •16. Presents with any of the following medical diagnoses/conditions at the time of screening:
- •a. Predominant squamous cell histology
- •17. Has a history of any of the following medical diagnoses/conditions:
- •a. Hemoptysis (= ½ tsp red blood)
- •b. Bleeding diathesis or coagulopathy
- •18. If female, is pregnant or breast-feeding;
- •19. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30
- •days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which
- •there is currently no regulatory-authority-approved indication);
- •20. Has previously received an organ or progenitor/stem cell transplant.
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