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NCT00874848 · ClinicalTrials.gov registry record · Phase 2
Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by HiberCell.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT00874848: Completed Phase 2 study, sponsored by HiberCell.
NCT00874848 is a Phase 2 study that has completed, run by HiberCell. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00874848, a Phase 2 study, has completed, sponsored by HiberCell.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
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 cetuximab 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.
Primary Outcome
Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and t
Interventions
- DRUG Carboplatin
- BIOLOGICAL Cetuximab
- DRUG Paclitaxel
- BIOLOGICAL Imprime PGG Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2009-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00874848 record still lists
NCT00874848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00874848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00874848 about?
NCT00874848 is a clinical study titled "Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced 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 cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study...
What is the current status of trial NCT00874848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2009-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00874848?
The interventions under investigation include: Carboplatin (DRUG), Cetuximab (BIOLOGICAL), Paclitaxel (DRUG), Imprime PGG Injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT00874848?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00874848's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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