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COMPLETED Phase 2

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

NCT00874107 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Bevacizumab
  • BIOLOGICAL Imprime PGG® Injection

Study Locations (10)

Other

  • 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

Arkansas

  • Highlands Oncology Group — Fayetteville

Ohio

  • Gabrail Cancer Center — Canton

Texas

  • University of Texas Health Science Center, San Antonio — San Antonio

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2009-06
Est. Completion 2016-05
Phase Phase 2

Sponsor

HiberCell

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00874107

The ClinicalTrials.gov registry entry for NCT00874107 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiberCell, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00874107 reports 10 study locations spanning 4 distinct geographic areas — top geographies include Other, Arkansas, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00874107 about?

NCT00874107 is a clinical study titled "Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)". 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 stu...

What is the current status of trial NCT00874107?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2009-06. Estimated completion is 2016-05.

What conditions does trial NCT00874107 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00874107?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Bevacizumab (BIOLOGICAL), Imprime PGG® Injection (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00874107?

This trial is sponsored by HiberCell, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00874107 being conducted?

This trial has 10 study locations across Arkansas, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial