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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


Inclusion Criteria:



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;

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:

1. ANC ≥ 1,500/μL

2. PLT ≥ 100,000/μL

3. HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;

9. Has adequate renal function as evidenced by:

1. Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab

2. 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:

1. Serum total bilirubin ≤ 1.0 mg/dL

2. AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic
metastases)

3. 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:

1. INR ≤ 1.5

2. PTT ≤ 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.

Exclusion Criteria:

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:

1. Central nervous system (CNS) metastases

2. Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two
agents for adequate control

3. Peripheral neuropathy ≥ grade 2 from any cause

4. Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing

5. 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:

1. Arterial or venous thromboembolic or hemorrhagic disorders including stroke,
transient ischemic attack or cerebral infarction

2. Deep vein thrombosis within 1 year prior to screening

3. 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

4. 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

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:

1. Hemoptysis (≥ ½ tsp red blood)

2. 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate (ORR) in each study arm

Outcome Time Frame:

Approximately 1.5 years

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

BT-CL-PGG-LCA0821

NCT ID:

NCT00874107

Start Date:

June 2009

Completion Date:

September 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Phase 2
  • Randomized
  • Efficacy
  • Safety
  • Imprime PGG
  • Bevacizumab
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Highlands Oncology GroupSpringdale, Arkansas  72764
Gabrail Cancer CenterCanton, Ohio  44718
University of Texas Health Science Center, San AntonioSan Antonio, Texas  78229