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NCT00617734 · ClinicalTrials.gov registry record · Phase 2
Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT00617734: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT00617734 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617734, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.
Primary Outcome
PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.
Interventions
- BIOLOGICAL IMC-A12 (cixutumumab)
- BIOLOGICAL cetuximab (Erbitux ®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT00617734 record still lists
NCT00617734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which IMC-A12 (cixutumumab) is the first listed.
NCT00617734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00617734 about?
NCT00617734 is a clinical study titled "Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck". The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.
What is the current status of trial NCT00617734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2008-03. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00617734?
The interventions under investigation include: IMC-A12 (cixutumumab) (BIOLOGICAL), cetuximab (Erbitux ®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00617734?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00617734's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 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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