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NCT01827111 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01827111: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01827111 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827111, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG Ipilimumab
- BEHAVIORAL Phone Call
- DRUG ABI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-04-25 |
| Est. Completion | 2020-09-21 |
| Phase | Phase 2 |
What the finished NCT01827111 record still lists
NCT01827111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Ipilimumab is the first listed.
NCT01827111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01827111 about?
NCT01827111 is a clinical study titled "Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma". The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Abraxane i...
What is the current status of trial NCT01827111?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2013-04-25. Estimated completion is 2020-09-21.
What interventions are being tested in trial NCT01827111?
The interventions under investigation include: Ipilimumab (DRUG), Phone Call (BEHAVIORAL), ABI-007 (DRUG).
Who is sponsoring clinical trial NCT01827111?
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 NCT01827111's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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