Status:
COMPLETED
Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
HiberCell, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with bevacizumab and concomitant paclitaxel ...
Eligibility Criteria
Inclusion
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC);
- Is between the ages of 18 and 75 years old, inclusive;
- Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer;
- Has non-squamous, non-small cell lung cancer
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
- Has an ECOG performance status of 0 or 1;
- Has a life expectancy of \> 3 months;
- Has adequate hematologic function as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
- Has adequate renal function as evidenced by:
- Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
- 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;
- Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- 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;
- Has adequate coagulation function as evidenced by:
- INR ≤ 1.5
- PTT ≤ ULN for the reference lab obtained within 1 week prior to the first dose of study medication;
- 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.
Exclusion
- Has received prior systemic chemotherapy at any time for lung cancer;
- Has received previous radiation therapy to \>30% of active bone marrow or any radiation therapy within 3 weeks of Day 1;
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection;
- Has had previous exposure to Betafectin® or Imprime PGG;
- Has an active infection;
- Presents with any of the following medical diagnoses/conditions at the time of screening:
- Central nervous system (CNS) metastases
- Uncontrolled hypertension (\>150/100 mmHg) or hypertension that requires \> two agents for adequate control
- Peripheral neuropathy ≥ grade 2 from any cause
- Fever of \>38.5° C within 3 days prior to screening or Day 1, initial dosing
- 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
- Has a history of any of the following medical diagnoses/conditions:
- Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic attack or cerebral infarction
- Deep vein thrombosis within 1 year prior to screening
- 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
- Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of \<2.0 ng/mL
- Has a known hypersensitivity to bevacizumab, murine proteins, or any component of bevacizumab;
- Has a know sensitivity to polyethoxylated castor oil;
- Has previously received treatment with bevacizumab;
- Has had surgery within 4 weeks of Day 1 or needle or open biopsy within 1 week of Day 1;
- Has a non-healing wound or gastric ulcer;
- Has a non-healed bone fracture;
- Is receiving systemic anti-coagulation therapy (e.g., dipyridalmole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®);
- 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;
- Presents with any of the following medical diagnoses/conditions at the time of screening:
- a. Predominant squamous cell histology
- Has a history of any of the following medical diagnoses/conditions:
- Hemoptysis (≥ ½ tsp red blood)
- Bleeding diathesis or coagulopathy
- If female, is pregnant or breast-feeding;
- 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);
- Has previously received an organ or progenitor/stem cell transplant.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00874107
Start Date
June 1 2009
End Date
May 1 2016
Last Update
March 3 2017
Active Locations (10)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Gabrail Cancer Center
Canton, Ohio, United States, 44718
3
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States, 78229
4
Kliniken der Stadt Köln gGmbH
Cologne, Germany