Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT00874107
Run by: HiberCell, Inc.
People needed: 90
Starts: 2009-06-01
Expected to finish: 2016-05-01
Last updated by the study team: 2017-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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:

Where it is running

Highlands Oncology Group — Fayetteville, Arkansas, United States
Gabrail Cancer Center — Canton, Ohio, United States
University of Texas Health Science Center, San Antonio — San Antonio, Texas, United States
Kliniken der Stadt Köln gGmbH — Cologne, Germany
Hospital Marth-Maria Halle Dolau — Halle, Germany
Clinical Kassel GmbH — Kassel, Germany
University of Mainz — Mainz, Germany
University of Munich — Munich, Germany
Pius-Hospital Oldenburg — Oldenburg, Germany
Universitätsklinikum Ulm — Ulm, Germany

Full record on ClinicalTrials.gov

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