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Non-Small Cell Lung CancerPhase 2NCT00874107

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 study testing Imprime PGG® Injection, Bevacizumab and Paclitaxel in people with Non-Small Cell Lung Cancer, run by HiberCell, Inc. at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Imprime PGG® Injection, Bevacizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
10 sitesin 2 countries
Study dates
Jun 2009to May 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • Has adequate coagulation function as evidenced by:
  • INR ≤ 1.5
  • PTT ≤ ULN for the reference lab 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.

Who cannot join

  • 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:
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  • 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
  • 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 bevacizumab, murine proteins, or any component of bevacizumab;
  • Has a know sensitivity to polyethoxylated castor oil;
  • Has previously received treatment with bevacizumab;
  • Has had surgery within 4 weeks of Day 1 or needle or open biopsy within 1 week of Day 1;
  • Has a non-healing wound or gastric ulcer;
  • Has a non-healed bone fracture;
  • Is receiving systemic anti-coagulation therapy (e.g., dipyridalmole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®);
  • 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;
  • Presents with any of the following medical diagnoses/conditions at the time of screening:
  • Predominant squamous cell histology
  • Has a history of any of the following medical diagnoses/conditions:
  • Hemoptysis (≥ ½ tsp red blood)
  • Bleeding diathesis or coagulopathy
  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Germany7 sites

  • Kliniken der Stadt Köln gGmbH

    Cologne

  • Hospital Marth-Maria Halle Dolau

    Halle

  • Clinical Kassel GmbH

    Kassel

  • University of Mainz

    Mainz

  • University of Munich

    Munich

  • Pius-Hospital Oldenburg

    Oldenburg

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

United States3 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • University of Texas Health Science Center, San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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.

Being tested
Imprime PGG® Injection, Bevacizumab, Paclitaxel, Carboplatin
Keywords
NSCLC, Phase 2, Randomized, Efficacy, Safety, Imprime PGG, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imprime PGG® InjectionBiological

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

  • BevacizumabBiological

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

  • PaclitaxelDrug

    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.

  • CarboplatinDrug

    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

Study groups in NCT00874107
Study groupRoleWhat they receive
1ExperimentalImprime PGG + bevacizumab + paclitaxel/carboplatin
Receives: Biological: Imprime PGG® Injection; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin
2Otherbevacizumab + paclitaxel/carboplatin
Receives: Biological: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Approximately 1.5 years

Secondary outcomes (7)

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

    Measured: Approximately 1.5 years

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

    Measured: Approximately 1.5 years

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

    Measured: Approximately 1.5 years

  4. To determine the duration of stable disease in each study arm

    Measured: Approximately 1.5 years

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

    Measured: Approximately 1.5 years

  6. To assess the safety of the dosing regimen within each study arm

    Measured: Approximately 1.5 years

  7. To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only)

    Measured: Approximately 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionApr 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00874107
Sponsor's protocol ID
BT-CL-PGG-LCA0821
Status last verified
Mar 2017
First submitted
1 Apr 2009
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18281559

  • 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.

    PubMed 29486797

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imprime PGG® Injection, Bevacizumab and Paclitaxel in people with Non-Small Cell Lung Cancer, run by HiberCell, Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the objective response rate (ORR) in each study arm (time frame: Approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00874107, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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