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

NCT00874107 | Completed Phase 2 DMC

• 1 other identifier: BT-CL-PGG-LCA0821
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; Phase 2; Randomized; Efficacy; Safety; Imprime PGG; Bevacizumab

Outcome Measures

Primary Outcomes (1)

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

  Approximately 1.5 years

Secondary Outcomes (7)

• To determine the disease control rate (DCR) in each study arm

  Approximately 1.5 years

• To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm

  Approximately 1.5 years

• To determine the duration of objective tumor response in each study arm

  Approximately 1.5 years

• To determine the duration of stable disease in each study arm

  Approximately 1.5 years

• To determine the duration of time to progression (TTP) in each study arm

  Approximately 1.5 years

Study Arms (2)

1

EXPERIMENTAL

Imprime PGG + bevacizumab + paclitaxel/carboplatin

Biological: Imprime PGG® Injection; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

2

OTHER

bevacizumab + paclitaxel/carboplatin

Biological: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Imprime PGG® Injection BIOLOGICAL

4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation

1

Bevacizumab BIOLOGICAL

15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle

1; 2

Paclitaxel DRUG

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.

1; 2

Carboplatin DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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

Sponsors & Collaborators

• HiberCell, Inc.: lead

Study Sites (10)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229, United States

Location

Kliniken der Stadt Köln gGmbH

Cologne, Germany

Location

Hospital Marth-Maria Halle Dolau

Halle, Germany

Location

Clinical Kassel GmbH

Kassel, Germany

Location

University of Mainz

Mainz, Germany

Location

University of Munich

Munich, Germany

Location

Pius-Hospital Oldenburg

Oldenburg, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Related Publications (2)

• 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. doi: 10.1158/1078-0432.CCR-07-1669.

  PMID: 18281559 BACKGROUND

• Engel-Riedel W, Lowe J, Mattson P, Richard Trout J, Huhn RD, Gargano M, Patchen ML, Walsh R, Trinh MM, Dupuis M, Schneller F. A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer. J Immunother Cancer. 2018 Feb 27;6(1):16. doi: 10.1186/s40425-018-0324-z.

  PMID: 29486797 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Folker Schneller, MD

  Klinikum rechts der Isar der Technischen Universitaet Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (3); DE (7)