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NCT00668148 · ClinicalTrials.gov registry record · Phase 2
A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT00668148: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT00668148 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00668148, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study Summary
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis: 1. Ewing's sarcoma/peripheral neuroectodermal tumor (PNET) 2. rhabdomyosarcoma 3. leiomyosarcoma 4. adipocytic sarcoma 5. synovial sarcoma. A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.
Primary Outcome
PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (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. Percentage of participants is calculated as th
Interventions
- BIOLOGICAL IMC-A12 (cixutumumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00668148 record still lists
NCT00668148 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which IMC-A12 (cixutumumab) is the first listed.
NCT00668148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00668148 about?
NCT00668148 is a clinical study titled "A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma". This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis: 1. Ewing's sarcoma/peripheral neuroectode...
What is the current status of trial NCT00668148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2008-07. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00668148?
The interventions under investigation include: IMC-A12 (cixutumumab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00668148?
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 NCT00668148's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 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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