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
- Conditions
- Patients with with Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung CancerMedDRA version: 17.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-006780-37-DE
- Lead Sponsor
- Biothera
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Diagnosis and Main Criteria for Inclusion in the Study:
Inclusion Criteria
To be considered eligible to participate in the study, a subject must meet all of the inclusion criteria listed below.
The subject:
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 version 1.0;
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:
a. ANC = 1,500/µL
b. PLT = 100,000/µL
c. HGB = 9 g/dL
obtained within 1 week prior to the first dose of study medication;
9. Has adequate renal function as evidenced by:
a. Serum creatinine = 1.5 X the upper limit of normal (ULN) for the reference lab
b. 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:
a. Serum total bilirubin = 1.0 mg/dL
b. AST = 2.5X ULN for the reference lab (= 5X ULN for subjects with known hepatic metastases)
c. 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:
a. INR = 1.5 X ULN for the reference lab
b. PTT = 1.5 X 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below.
The subject:
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:
a. Central nervous system (CNS) metastases
b. Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for
adequate control
c. Peripheral neuropathy = grade 2 from any cause
d. Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
e. 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:
a. Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic
attack or cerebral infarction
b. Deep vein thrombosis within 1 year prior to screening
c. 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
d. Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intraepithelial
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:
a. Hemoptysis (= ½ tsp red blood)
b. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method