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NCT01028222 · ClinicalTrials.gov registry record · Phase 2
A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT01028222: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01028222 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01028222, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.
Primary Outcome
ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline
Interventions
- DRUG Nilotinib
- DRUG DTIC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01028222 record still lists
NCT01028222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Nilotinib is the first listed.
NCT01028222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01028222 about?
NCT01028222 is a clinical study titled "A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation". The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.
What is the current status of trial NCT01028222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2010-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01028222?
The interventions under investigation include: Nilotinib (DRUG), DTIC (DRUG).
Who is sponsoring clinical trial NCT01028222?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01028222's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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