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

NCT00874107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-03-03

No results posted yet for this study

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

Interventions

BIOLOGICAL

Imprime PGG® Injection

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

BIOLOGICAL

Bevacizumab

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

DRUG

Paclitaxel

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.

DRUG

Carboplatin

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

Sponsors & Collaborators

  • HiberCell, Inc.

    lead INDUSTRY

Principal Investigators

  • Folker Schneller, MD · Klinikum rechts der Isar der Technischen Universitaet Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • United States
  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00874107 on ClinicalTrials.gov