Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: NSCLC

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 cetuximab 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

NCT00874848

Run by

HiberCell, Inc.

People needed

90

Starts

2009-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-11-29

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 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;
• 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:
• 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 cetuximab, murine proteins, or any component of cetuximab
• Has a know sensitivity to Cremophor EL
• Has previously received treatment with cetuximab
• 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.

Where it is running

• Medical College of Georgia — Augusta, Georgia, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Allison Cancer Center — Midland, Texas, United States
• Helios Clinic Emil von Behring — Berlin, Germany
• Municipal Clinic Frankfurt Hoescht — Frankfurt, Germany
• Georg-August University Gottingen — Göttingen, Germany
• University Clinical Heidelberg — Heidelberg, Germany
• Clinic Minden — Minden, Germany
• Techincal University of Munich — Munich, Germany
• Clinic Nurnberg Nord — Nuremberg, Germany
• Universitätsklinikum Ulm — Ulm, Germany
• HELIOS Klinikum Wuppertal, Medizinische Klinik 1 — Wuppertal, Germany

Full record on ClinicalTrials.gov

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