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About
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 and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Has adequate renal function as evidenced by:
Has adequate hepatic function as evidenced by:
Has adequate coagulation function as evidenced by:
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 criteria
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:
Has a history of any of the following medical diagnoses/conditions:
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:
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.
Primary purpose
Allocation
Interventional model
Masking
90 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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