Clinical Trials/NCT00874107

NCT00874107

Completed

Phase 2

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

HiberCell, Inc.10 sites in 2 countries90 target enrollmentJune 2009

ConditionsNon-Small Cell Lung Cancer

InterventionsImprime PGG® Injection Bevacizumab Paclitaxel Carboplatin

DrugsPaclitaxel Carboplatin

Overview

Phase: Phase 2
Intervention: Imprime PGG® Injection
Conditions: Non-Small Cell Lung Cancer
Sponsor: HiberCell, Inc.
Enrollment: 90
Locations: 10
Primary Endpoint: To determine the objective response rate (ORR) in each study arm
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HiberCell, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

1

Imprime PGG + bevacizumab + paclitaxel/carboplatin

Intervention: Imprime PGG® Injection

1

Imprime PGG + bevacizumab + paclitaxel/carboplatin

Intervention: Bevacizumab

1

Imprime PGG + bevacizumab + paclitaxel/carboplatin

Intervention: Paclitaxel

1

Imprime PGG + bevacizumab + paclitaxel/carboplatin

Intervention: Carboplatin

2

bevacizumab + paclitaxel/carboplatin

Intervention: Bevacizumab

2

bevacizumab + paclitaxel/carboplatin

Intervention: Paclitaxel

2

bevacizumab + paclitaxel/carboplatin

Intervention: Carboplatin

Outcomes

Primary Outcomes

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

Time Frame: Approximately 1.5 years

Secondary Outcomes

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)
To assess the safety of the dosing regimen within each study arm(Approximately 1.5 years)
To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only)(Approximately 1.5 years)
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)