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NCT01152788 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma
A Phase 2 study, sponsored by NCIC Clinical Trials Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01152788: Completed Phase 2 study, sponsored by NCIC Clinical Trials Group.
NCT01152788 is a Phase 2 study that has completed, run by NCIC Clinical Trials Group. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01152788, a Phase 2 study, has completed, sponsored by NCIC Clinical Trials Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment. This research is being done because currently there is no effective treatment for this type of cancer.
Primary Outcome
Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.
Interventions
- DRUG Dacarbazine
- DRUG rIL-21
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2010-08-05 |
| Est. Completion | 2015-02-13 |
| Phase | Phase 2 |
What the finished NCT01152788 record still lists
NCT01152788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Dacarbazine is the first listed.
NCT01152788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01152788 about?
NCT01152788 is a clinical study titled "Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma". The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests...
What is the current status of trial NCT01152788?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2010-08-05. Estimated completion is 2015-02-13.
What interventions are being tested in trial NCT01152788?
The interventions under investigation include: Dacarbazine (DRUG), rIL-21 (DRUG).
Who is sponsoring clinical trial NCT01152788?
This trial is sponsored by NCIC Clinical Trials Group, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01152788's enrollment target sits among peer trials
64 996th of 2000 higher than 992 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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