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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 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 113 participants.
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.
Interventions
- BIOLOGICAL IMC-A12 (cixutumumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00668148
The ClinicalTrials.gov registry entry for NCT00668148 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IMC-A12 (cixutumumab) is the first listed.
NCT00668148 reports 0 study locations.
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.
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