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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biothera
ClinicalTrials.gov Identifier:
NCT00874107
First received: April 1, 2009
Last updated: March 13, 2013
Last verified: March 2013

April 1, 2009
March 13, 2013
June 2009
July 2013   (final data collection date for primary outcome measure)
To determine the objective response rate (ORR) in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00874107 on ClinicalTrials.gov Archive Site
  • To determine the disease control rate (DCR) in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the duration of objective tumor response in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the duration of stable disease in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the duration of time to progression (TTP) in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To assess the safety of the dosing regimen within each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only) [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Biological: Imprime PGG® Injection
    4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
  • Biological: Bevacizumab
    15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
  • Drug: Paclitaxel
    200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.
  • Drug: Carboplatin
    AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
  • Experimental: 1
    Imprime PGG + bevacizumab + paclitaxel/carboplatin
    Interventions:
    • Biological: Imprime PGG® Injection
    • Biological: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • 2
    bevacizumab + paclitaxel/carboplatin
    Interventions:
    • Biological: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
Salvador C, Li B, Hansen R, Cramer DE, Kong M, Yan J. Yeast-derived beta-glucan augments the therapeutic efficacy mediated by anti-vascular endothelial growth factor monoclonal antibody in human carcinoma xenograft models. Clin Cancer Res. 2008 Feb 15;14(4):1239-47.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
September 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00874107
BT-CL-PGG-LCA0821
Yes
Biothera
Biothera
Not Provided
Not Provided
Biothera
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP