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NCT01624766 · ClinicalTrials.gov registry record · Phase 1
Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT01624766: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01624766 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624766, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of everolimus when given together with anakinra or denosumab in treating participants with cancers that have spread to other places in the body and have come back or aren't responding to treatment. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and the spread of cancer. Monoclonal antibodies, such as denosumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and anakinra or denosumab may work better in treating participants with advanced cancers.
Primary Outcome
If more than 33% of patients enrolled at any particular dose level develop dose limiting toxicity (DLT), the treatment will continue at the dose level immediately below. If not more than 33% of the patients in the cohort develop DLT, this cohort will be considered the MTD. Only DLTs within course 1 (4 weeks) will be counted with respect to the dose-escalation algorithm.
Interventions
- DRUG Everolimus
- BIOLOGICAL Denosumab
- BIOLOGICAL Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-06-19 |
| Est. Completion | 2021-02-24 |
| Phase | Phase 1 |
What the finished NCT01624766 record still lists
NCT01624766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.
NCT01624766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01624766 about?
NCT01624766 is a clinical study titled "Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers". This phase I trial studies the side effects and best dose of everolimus when given together with anakinra or denosumab in treating participants with cancers that have spread to other places in the body and have come back or aren't responding to treatment. Everolimus may stop the growth of tumor cell...
What is the current status of trial NCT01624766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2012-06-19. Estimated completion is 2021-02-24.
What interventions are being tested in trial NCT01624766?
The interventions under investigation include: Everolimus (DRUG), Denosumab (BIOLOGICAL), Anakinra (BIOLOGICAL).
Who is sponsoring clinical trial NCT01624766?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01624766's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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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