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NCT01251926 · ClinicalTrials.gov registry record · Phase 1
EZN-2208 (Pegylated SN-38) in Combination With Bevacizumab in Refractory Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01251926: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01251926 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251926, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Background: \- The anticancer drug bevacizumab works by reducing the formation of new blood vessels in tumors, which can slow or stop the growth of cancer cells and supporting blood vessels. The experimental drug EZN-2208 works by limiting how well cancer cells can divide. Drugs similar to EZN-2208 also work by turning off the production of the HIF protein, which otherwise can help cancer cells to grow even when blood supply is limited. Researchers are interested in determining if EZN-2208 turns off HIF in patient tumors, and whether combining it with bevacizumab is an effective treatment for cancers that have not responded to standard treatment. Objectives: \- To assess the safety and effectiveness of the combination of EZN-2208 and bevacizumab for solid tumors that have not responded to standard treatment. Eligibility: \- Individuals at least 18 years of age who have solid tumors that have not responded to standard treatment. Design: * Participants will be screened with a full physical examination and medical history, blood and urine samples, and tumor imaging studies. * Participants will receive EZN-2208 and bevacizumab intravenously on an outpatient basis in 4-week cycles (with the exception of the first cycle, which will be 5 weeks). * Cycle 1: Participants will receive EZN-2208 once a week for 3 weeks in a row (days 1, 8, and 15), followed by 1 week without the drug. Participants will receive bevacizumab 1 week before EZN-2208 (day - 7) and then 3 weeks later (day 15). * Subsequent cycles: Participants will receive EZN-2208 once a week for 3 weeks in a row (days 1, 8, and 15), followed by 1 week without the drug. Participants will receive bevacizumab every 2 weeks (days 1 and 15). * Participants will have clinic visits with physical examinations and blood tests in the first 3 weeks of each cycle. Clinic visits may also include tumor imaging studies and tumor biopsies as directed by the study researchers. * Participants will continue to take the study dr
Interventions
- DRUG Bevacizumab
- DRUG EZN-2208
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-11-15 |
| Est. Completion | 2014-04-23 |
| Phase | Phase 1 |
What the finished NCT01251926 record still lists
NCT01251926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT01251926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01251926 about?
NCT01251926 is a clinical study titled "EZN-2208 (Pegylated SN-38) in Combination With Bevacizumab in Refractory Solid Tumors". Background: \- The anticancer drug bevacizumab works by reducing the formation of new blood vessels in tumors, which can slow or stop the growth of cancer cells and supporting blood vessels. The experimental drug EZN-2208 works by limiting how well cancer cells can divide. Drugs similar to EZN-2208...
What is the current status of trial NCT01251926?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-11-15. Estimated completion is 2014-04-23.
What interventions are being tested in trial NCT01251926?
The interventions under investigation include: Bevacizumab (DRUG), EZN-2208 (DRUG).
Who is sponsoring clinical trial NCT01251926?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01251926's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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