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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
HiberCell, Inc.
Study ID
NCT00874107
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Imprime PGG® Injection — BIOLOGICAL
    4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
  • Bevacizumab — BIOLOGICAL
    15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
  • 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.
  • 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

Study Details

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.

Key Dates

First listed
Apr 2, 2009
Start date
Jun 30, 2009
Status verified
Mar 2017
Primary completion
Apr 30, 2016
Completion
May 31, 2016

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Imprime PGG + bevacizumab + paclitaxel/carboplatin
  • Other: 2
    bevacizumab + paclitaxel/carboplatin

Primary Outcome Measure

To determine the objective response rate (ORR) in each study arm [ Time Frame: Approximately 1.5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
Gabrail Cancer CenterCantonOhio44718-
University of Texas Health Science Center, San AntonioSan AntonioTexas78229-

Find similar trials in Fayetteville, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group· Fayetteville, ARGabrail Cancer Center· Canton, OHUniversity of Texas Health Science Center, San Antonio· San Antonio, TX

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